Manager, Quality Systems Resume Sample

4.6
16 votes
Resume Create

The Resume Builder

Create a Resume in Minutes with Professional Resume Templates

Casey Hoppe
258 Madonna Fork,  New York, NY
+1 (555) 825 1443

Work Experience


Manager, Quality Systems
02/2016 - PRESENT
Phoenix, AZ
  • Initiates, monitors and completes change controls related to Quality topics
  • Reviews and approves supplier documents requiring Quality approval
  • Initiates, revises, and reviews controlled cGMP documents including SOPs, specifications and reports
  • Executes and/or reviews Quality System-related validation test scripts and documents
  • Provides training on department specific procedures and systems
  • Collects data, calculates, and reports on departmental performance metrics
  • Reviews and approves process, assay, and other validation protocols and reports, as applicable
  • Identifies and plans projects/studies/reviews/investigations to address a specific issues
Senior Manager, Quality Systems
11/2009 - 09/2015
Detroit, MI
  • Acts as an advisor to specialists executing projects
  • Interacts with management, peers, subordinates and externally, to assess and improve the adequacy of the quality management system processes and procedures
  • Assures quality and compliance of department work product
  • Maintains knowledge of current applicable global regulatory requirements
  • Applies knowledge of cGMPs on a daily basis
  • Manages day-to-day operations independently
  • Routinely partners with senior management on critical issues
  • Manages, analyzes, and reviews metrics concerning the product change control process and resulting records.
Manager Quality Systems / Audits
11/2005 - 09/2009
Chicago, IL
  • Acts as a quality systems consultant, advising Oncology & Biology Quality project teams in planning and executing commercial product changes and product launch projects.
  • Responsible for mentoring/coaching/training of cross-functional staff both at site and externally (e.g., QA and QC personnel, Pharmaceutical Operations personnel, )
  • Sets vision and goals that are aligned with Takeda Quality
  • Determines/ensures proper sequencing of product change control activities by cross-functional resources such that activities are conducted according to established procedures, ensuring compliance is maintained
  • Meets with individual employees and/or groups, both on site and remotely, on a regular basis to discuss, prioritize, and assign work and projects
  • Meets with functional group on a regular basis to discuss routine activities, individual projects and departmental goals
  • Develops and maintains strong internal relationships within the Quality organization, cross-functionally within Oncology & Biologics and cross-divisionally with R&D, and CMC Center
  • Manages the daily operations of quality and lean activities, including quality system and audits, continuous improvement programs, operational safety, and regulations requirements coordination

Education


Southern Illinois University Carbondale
2001 - 2005
Bachelor's Degree in Food Science

Professional Skills


  • Strong project management skills; excellent organizational skills and flexibility for multi-task situations; good problem solving skills
  • Excellent grammar and verbal skills; excellent English written and verbal communication skills
  • Excellent interpersonal and communication skills with senior management, including technical writing skills
  • Excellent communication skills, including written, verbal, and presentation skills
  • Strong verbal and written communication skills and computer skills are required
  • Proven leadership skills demonstrated thru building and engaging a high performing team – can follow as well as lead
  • Excellent time management skills, including an ability to manage multiple and frequently changing projects and priorities

How to write Manager, Quality Systems Resume

Manager, Quality Systems role is responsible for presentation, english, organizational, software, communications, leadership, reporting, training, integration, auditing.
To write great resume for manager, quality systems job, your resume must include:

  • Your contact information
  • Work experience
  • Education
  • Skill listing

Contact Information For Manager, Quality Systems Resume

The section contact information is important in your manager, quality systems resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:

  • First and last name
  • Email
  • Telephone number

Work Experience in Your Manager, Quality Systems Resume

The section work experience is an essential part of your manager, quality systems resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous manager, quality systems responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular manager, quality systems position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions.

Representative Manager, Quality Systems resume experience can include:

  • Manages staff and associated resources for quality-assurance coverage; builds and supports a high-performing team by managing goals/metrics, providing timely feedback on performance, and facilitating the talent-management process
  • Develops and implements effective programs, procedures, processes, goals, and methods to ensure compliance with regulatory requirements, corporate quality policies, and applicable industry quality standards
  • Excellent communication and presentation skills (listening, written and verbal) in English
  • Excellent organizational skills and ability to review and update processes or procedures
  • Years of relevant experience: 10 years of food industry quality plant / systems experience with demonstrated achievement in Quality Leadership
  • Demonstrate leadership and management skills with previous engagement

Education on a Manager, Quality Systems Resume

Make sure to make education a priority on your manager, quality systems resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your manager, quality systems experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.

Additional details to include:

  • School you graduated from
  • Major/ minor
  • Year of graduation
  • Location of school

These are the four additional pieces of information you should mention when listing your education on your resume.

Professional Skills in Manager, Quality Systems Resume

When listing skills on your manager, quality systems resume, remember always to be honest about your level of ability. Include the Skills section after experience.

Present the most important skills in your resume, there's a list of typical manager, quality systems skills:

  • Strong organizational, coaching, interpersonal, technical and time management, problem solving, and multi-tasking skills
  • Strong team-building skills; Acts to promote commitment to a team task or goal
  • Demonstrated ability to effectively manage multiple moderately complex projects simultaneously
  • Effective interpersonal skills at any level within the organization
  • Demonstrated leadership skills associated with the management, leadership and development of staff
  • Solid knowledge of applicable software, statistical, trending and risk analysis skills

List of Typical Experience For a Manager, Quality Systems Resume

1

Experience For Senior Manager, Quality Systems Resume

  • In a technical role in technical operations, quality engineering, validation, quality assurance or quality systems
  • Experience in inspection management and interacting with regulators
  • Excellent working knowledge of pharmaceutical quality system requirements and international regulatory requirements
  • Past experience working with sterile injectable drugs and ASQ Certifications (e.g., CQE, CQA) are desirable
  • Strong knowledge of GMP, SOPs and quality system processes
2

Experience For Manager Quality Systems Resume

  • Training and Knowledge Management process
  • Provide coaching, mentoring and leadership to the Quality staff
  • Develop, execute and analyze quality-reporting measures. KPI reporting to ensure achievement of overall company goals
  • Supervises the work of document control and system team members. Including auditing team
  • Provide quality viewpoints and opinions in the planning of future product/site development
  • Manage the complaint handling processes to insure customer responsiveness and product and process improvements
  • Works with adhesive suppliers to continuously improve bonding techniques to reduce VOV and to improve labor efficiency and quality
  • Advanced knowledge of computer software in order to perform trending and prepare presentations to management (MS Word, MS Excel, MS PowerPoint, etc.)
3

Experience For Manager Quality Systems / Audits Resume

  • Directs and exercises authority for planning, organization, control, integration and completion of projects
  • Manages all product and process audits and the corrective/preventive action system used to ensure compliance
  • Consolidates, analyzes, and reports key quality system metrics on a regular basis to identify areas for improvement; leads the management team in the review of facilities' quality system metrics using disciplined problem-solving techniques to identify, implement, and correct/prevent actions
  • Establishes project plans and manage initiatives based on defined priorities, anticipating cross-functional and cross-team collaboration opportunities, and coaches team members on timely and accurate accomplishment of goals, providing access to development experiences as appropriate
  • Identify and assess resource needs and skills that support the vision and values of JJVS. Hire, train, manage and develop Quality professionals in order to improve group effectiveness and productivity
  • Contribute to the development of operational policies and procedures that affect personnel within the assigned organizational unit and cross functional affected areas
  • Monitor daily work operations and provide direction and guidance to staff to achieve unit or project goals. Interact with internal and external customers, by meeting regularly, responding to requests and explaining procedures
  • Experience in leading an organization to high levels of compliance
4

Experience For Manager, Quality Systems EXT MFG Resume

  • Use data driven business cases for project and resource justifications. Optimize workflow processes for quality system documentation and archiving of records
  • Ensure compliance with company policies and procedures (e.g. compliance with FDA and applicable international regulations etc.)
  • Act as Subject Matter Expert in document control and labeling processes and support internal and external audits within the Document and Labeling Control groups
  • Provide input to Quality Management Review and supporting processes
  • Develop and implement Quality and compliance training programs that provide necessary organizational knowledge to achieve company and regulatory objectives including compliance
  • Adhere to/Manage the department budget
  • Certified Quality Engineering (CQE), Certified Quality Auditor (CQA), CBA (Certified Biomedical Auditor), CMQ/OE (Certified Manager of Quality / Operational Excellence) or Six Sigma Black Belt desired
  • BS in Engineering or related field required, MBA desired
5

Experience For Project Manager Quality Systems & Compliance Resume

  • Lead the organization's continuous improvement process; including data analysis, CAPA management; improvement projects and process capability to improve key metrics as measured by the product/process quality dashboard
  • Ensure site-level production, process and environmental controls
  • Lead supplier quality improvement strategies and tactics
  • Ensure compliance to the New Product/Site Development process and assurance that the Product Requirements Document includes key quality performance metrics
  • Work closely with Senior Management to provide strategic direction and development of site quality strategies and tactics
  • Lead site quality teams to ensure alignment to manufacturing/processing operations, support of Lean efforts and drive quality improvement performance for products and services
6

Experience For Senior Manager Quality Systems Resume

  • The position requires a B.S. in an engineering field, or in other pertinent science or technical field. Advanced degrees or Quality Certifications are also desirable: CQE, CQA, CQMgr., Six Sigma or Lean. Advanced degrees desirable
  • Work effectively with other NCR and CAPA site leaders to ensure consistent systems and processes at Ethicon plants
  • This is a management position involving the supervision of individuals comprised of technical, non-technical and/or professional employees
  • Lead the Quality staff to ensure compliance to the overall Quality Management System and to drive Continuous Improvement
  • Ensure and drive compliance with appropriate domestic regulatory and international standards and requirements
  • Lead the organization's continuous improvement process; including data analysis, improvement projects and process capability to improve key metrics as measured by the product/process quality dashboard
  • Ensure compliance to the New Product Development process and assurance that the Product Requirements Document includes key quality performance metrics
  • Assess new designs for manufacturability, testability and reliability to ensure the Quality risks and deliverables of the New Product Development process meet the required application reliability and design intent
7

Experience For Manager Quality Systems & Compliance Resume

  • Determine supplier qualification risks based upon criticality of component and supplier process capability
  • The position requires a level of authority to conduct and direct certain required activities. Examples of this are: Design reviews, Quality Plans, Device Master Record Indexes, Supplier Surveys, Device History Records, Inspection work cards, test procedures, product development verification and process validation
  • Lead the site’s quality improvement process; including data analysis, improvement projects and process capability to improve key metrics as measured by the product/process quality dashboard
  • Identify and assess resource needs and skills that support the vision and values of JJSV. Hire, train, manage and develop Quality professionals to proactively support business needs while supporting career aspirations
  • Contribute to the development and optimization of operational policies and procedures that affect personnel within the assigned organizational unit and cross functional affected areas
  • Provide education and mentoring as needed regarding NCR and CAPA
  • Act as Subject Matter Expert in document/change control, PLM systems, and support internal and external audits within the area
  • Manages the implementation and administration of quality management systems in accordance with applicable standards
  • Requests data and metrics reports obtained from quality databases and files for inclusion in management reports
8

Experience For Manager, Quality Systems Footwear Resume

  • Examines results from management reviews, third party inspections and internal audits and approves proposed corrective actions
  • Represent the site on the world-wide NCR and CAPA teams
  • Lead quality systems and compliance improvement, ·which result from Internal / External Audits, Management Review and / or any other CAPA / NCR system indicator
  • Serves as the initial point of contact for Product Complaints / Product Risk Escalation and ensures Risk Assessment is timely and adequately addressed
  • Oversees the complaint product evaluations activities for the site and maintains track and trending of product performance / results of product evaluations for escalation to CAPA
  • Ensure compliance to cGMP, EN ISO 13485, MDD, MDR and EN ISO 14971 and compliance to the Smith & Nephew relevant internal procedures and policies. Evaluate and approve plant documentation to ensure compliance to standards/regulations, corporate policies/procedures, DOPs and other plant documentation
  • Oversee the CAP program and ensures the robustness of CAPA investigations, corrections and corrective/preventive actions. Ensure the CAPA process complies with regulatory requirements, corporate and local procedures
  • Plan and manage the development and execution of quality process improvement activities to strengthen the site’s quality system
  • Responsible for quality and compliance training requirements. Maintain qualified personnel and ensure that the required initial and continuing training of site personnel (Austin/Irvine) are carried out. Assure adequate and robust training programs are established and updated as necessary
9

Experience For Manager, Quality Systems Operations Resume

  • Provide overall Quality Systems leadership including: direction of the personnel and activities of the team members
  • Support post market surveillance activities, management review, and audits/inspections
  • Provide expert level guidance and direction of the Quality Systems Body-of-Knowledge
  • Aggressively identify opportunities to apply, continuously improve, and redefine quality systems and controls for all the product-related processes in accordance with applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc
  • Aggressively identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility
  • Provide influential leadership with International sites to drive proactive quality system improvements
  • Identify Quality Initiatives and lead cross-functional teams to complete them
10

Experience For Manager, Quality Systems Document Control Resume

  • In coordination with the divisional training function, oversee, develop and provide training to divisional personnel on Quality Management System topic training
  • Travel to support domestic and international manufacturing sites (up to 15%)
  • Provide diligent and fact-based communication to Executive Management team, peers, and team on Quality Systems initiatives and changes
  • Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed
  • Provide guidance, leadership and organizational support for Product Development projects

List of Typical Skills For a Manager, Quality Systems Resume

1

Skills For Senior Manager, Quality Systems Resume

  • Excellent organization skills and ability to work on a number of projects to tight timelines
  • Excellent people and organizational skills, Ability to manage/coach/supervise a team
  • Excellent interpersonal skills and refined ability to influence without authority
  • Excellent interpersonal communication, collaborative teamwork, conflict management and negotiation skills
  • Facilitation, root cause analysis, structured problem-solving methodologies, technical writing skills/certifications are desired, but not required
  • Lead major issues, when appropriate. Leverage Process Excellence tools to effectively implement CAPA using a DMAIC approach
  • Interact effectively with internal and external customers in order to accomplish goals
  • Demonstrated managerial experience in Quality Assurance or related function
2

Skills For Manager Quality Systems Resume

  • Delegate effectively, lead staff, and manage Quality Systems activities in a fast-paced environment
  • Prior experience with ComplianceWire and/or MasterControl desirable
  • Hands-on experience of validating non-product software (i.e., CSV/SDLC)
  • Good Manufacturing and Sanitation Practices experience required
  • Experience with semi-solid dose products
  • Prior experience in Learning Management System (LMS) requirements analysis, quality systems training, and/or training curricula development
3

Skills For Manager Quality Systems / Audits Resume

  • Effectively influence seniors, peers, and subordinates
  • Proven experience in implementing quality systems in an FDA/ISO regulated environment
  • Demonstrated experience managing associates to include technicians and/or analysts
  • Attention to detail and accuracy and Problem-Solving Skills
  • Project management skills for projects spanning across different functional and international environments
  • Demonstrated experience with leading teams or projects is required
4

Skills For Manager, Quality Systems EXT MFG Resume

  • Understanding and experience in the application of FMECA and DOE
  • Working knowledge of Good Documentation Practices (GDP)
  • Knowledge of and working experience with Document Systems, Change Management, Training, and Auditing
  • Skilled at managing ambiguity, influencing without authority and driving for results
  • Experience in project management (managing projects, defining scope, tracking milestones)
  • Expert in root cause analysis and problem solving tools – demonstrated excellence in training problem solving in large and small settings
  • Strong understanding of industry core tools and documents. Including PFMEA, Control Plan, Process Flow Chart and drawings (GD&T)
  • Supervisory and management experience, focus on attracting a high performing, highly engaged workforce
5

Skills For Project Manager Quality Systems & Compliance Resume

  • Experience working with and leading diverse and cross functional teams
  • Partner with IT and the data warehouse team to drive improvements in business intelligence to facilitate effective tracking and trending
  • Direct experience with managing key Quality Management System processes, such as CAPA, Deviation Management, Change Management and Management Review
  • Experience in applying ICH guidelines, such ICH Q9 and ICH Q10
  • Experience working in cross-functional teams required
  • Strong working knowledge of cGMP regulations (for e.g., 21CFR210, 211, Part 4, 21CFR820 and ISO13485), and ICH guidance’s
  • Experience in document control and/or working with quality systems in a highly regulated industry
6

Skills For Senior Manager Quality Systems Resume

  • Experience in regulatory audits by FDA and ISO. Competence in the selection and use of Quality Engineering Tools and Techniques
  • Experience leading efforts in remediation of quality system deficiencies
  • Work on multiple projects, managing a broad range of tasks and prioritizing activities
  • Experience in Kaizen events
  • Excellent attention to detail, and ability to consistently meet high standards of quality required in QA Compliance
  • Prepare and conduct periodic management review to report on the effectiveness of the quality system
  • Review RCCA responses and validate findings to closure
  • Five-to-seven years of relevant pharmaceutical industry, Quality Assurance, experience
7

Skills For Manager Quality Systems & Compliance Resume

  • Direct experience with manufacturing of biopharmaceuticals, preferably drug product
  • Demonstrated proficiency leading negotiations
  • Demonstrated track record in people management including roles definition, team optimization, and conflict resolution
  • Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness
  • 5 – 8 years of manufacturing experience
8

Skills For Manager, Quality Systems Footwear Resume

  • Experience with food manufacturing regulations (FDA and USDA) required
  • Experience in cGMP or ISO quality system manufacturing environment
  • Experience with Root Cause Analysis Tools, Lean Manufacturing, and Six Sigma
  • Experience in Quality Systems and determining reportability to the FDA and other regulatory agencies
  • Experience at the supervisory/management level in the pharmaceutical industry
  • Strong knowledge and application of pharmaceutical, Health Canada and FDA regulations
9

Skills For Manager, Quality Systems Operations Resume

  • Experience (Quality System, Quality Assurance, or similar role) in the pharmaceutical/biotech industry
  • Experience in a team matrix environment and independently interact with various levels of management
  • Hands-on experience using PLM software systems, e.g.., Agile
  • Direct experience in a quality and/or compliance role in medical devices industry
  • Hands-on experience in managing and driving CAPAs, including use of root cause analysis tools
  • Good understanding of vaccines or similar biologics as well as raw material manufacturing technologies
10

Skills For Manager, Quality Systems Document Control Resume

  • Regulatory compliance experience related to archiving, document retention, and records controls
  • Experience in Quality Systems/Assurance Role or applicable role and at least 10 years in a regulated medical device/diagnostic industry
  • Global quality systems experience
  • Experience with inspections by the FDA & Certified Body
  • Software validation; The Food and Drug Administration’s Quality System Regulations (FDA’s QSR, ISPE GAMP 5)
  • Strong knowledge of regulatory requirements (21 CFR Parts 210, 211, 820)
  • Demonstrates in-depth knowledge of QA systems principles, concepts, industry practices, and standards

List of Typical Responsibilities For a Manager, Quality Systems Resume

1

Responsibilities For Senior Manager, Quality Systems Resume

  • Manages and coordinates the activities of local related T1 quality departments (which can be laboratory and/or chemical department and/or local product testing) according to adidas-Group standards to make them a reliable and independent partner
  • Guides implementation of QIP (including rubber and EVA rooms) systems and laboratory set-ups, as well as standard SOPs for polymer compounds at new T1 facilities
  • Demonstrated experience in leading teams, organizing and managing projects including development, coaching, and guiding team members
  • Previous supervisory and/or managerial experience. Experience hiring, conducting performance reviews, and taking corrective action
  • Experience in handling regulatory and external audits
  • Significant experience and understanding of quality assurance processes within the medical device industry with an analytical and organized approach
  • Experience in leading subordinate staff to high levels of compliance
2

Responsibilities For Manager Quality Systems Resume

  • Past experience in leading continuous improvement efforts, in both quality systems and products
  • Experience with root cause analysis, statistics, lean manufacturing and six sigma
  • Adapt to changing tasks and priorities and execute in a timely fashion
  • Experience in leading organizations through FDA, Notified Body and other International Reg Agency Audits
  • Experience serving in a leadership capacity for quality system activities required
  • Experience leading cross-site/cross-division projects required
  • Manages implementation of 3rd party finished goods inspections at all T1 suppliers
  • Working knowledge of medical device regulations, e.g., 21 CFR Part 820, ISO 13485, CMDR, MDD/ EU MDR, MHLW; and related labeling and packaging standards
3

Responsibilities For Manager Quality Systems / Audits Resume

  • Working knowledge of appropriate IS0, MDSAP, FDA, EPA and international regulatory standards
  • Working knowledge in the application of Risk Management
  • Establishing systemic process for review Change Orders in accordance with industry standard GMP practices
  • Establish and maintain successful cross-functional relations with R&D, Engineering, Manufacturing, Marketing, Quality and Regulatory Affairs departments
  • Proficient in drafting and completing technical documents and presentations
  • Coordinate Quality Engineering and In Process Quality Engineering areas engineers’ functions and activities
  • Provide direction for the overall QMS strategy. Lead improvement processes, executing and leading projects
4

Responsibilities For Manager, Quality Systems EXT MFG Resume

  • Resolve conflict and disputes by addressing multiple viewpoints to develop a mutually satisfying outcome
  • Build and maintain working knowledge of company product offering
  • LicenciatureIndustrial, Electronic, Biotechnology, Electromechanical Engineering or related field
  • Oversee and/or manage Management Review and Quality Planning Review and related forums
  • Ensure development and delivery of training for QMS areas of expertise
  • Represent expertise during internal and external quality system audits
  • Prepares and conducts training on Global QMS contents and structure to new acquisitions
5

Responsibilities For Project Manager Quality Systems & Compliance Resume

  • Leads the implementation of overarching Global Quality Management System programs or projects as a result of
  • Identify and support quality systems improvement initiatives by working closely with Global Quality department and other key stakeholders
  • Manage the development, monitoring and maintenance of GMP/QSR standards and processes to ensure compliance with local and federal regulations
  • Understands and assures conformance to regulations and Baxter quality policies applicable to the site. Interfaces with regulators during inspections
  • Works closely with Manufacturing in areas of GMP compliance
  • Responsible for maintaining the CAPA process, specifically
  • 1) Regulated quality management in direct manufacturing environment with class I, II and III medical devices
  • 2) SAP (including document control and quality systems modules)
  • 3) Management of database for CAPA tracking (such as Agile or ETQ)
6

Responsibilities For Senior Manager Quality Systems Resume

  • 4) CAWeb and TipQA for nonconformance tracking; and
  • BS in Engineering or related field required, MBA desirable
  • Apply problem solving mindset in various settings
  • Communicate clearly, accurately and directly – both verbally and in writing – to a widely varied audience in English and ideally French
  • Expertise in quality system standards and regulations, including FDA 820, ISO 13485 and international standards, such as EU MDR, CMDCAS and Chinese GMPs
  • Flexibility to work varying schedules to support occasional weekend, holiday and off shift work hours
7

Responsibilities For Manager Quality Systems & Compliance Resume

  • Handle a demanding and varied workload, be very organized, and assertive
  • Act as quality management representative during the absence of the site quality director
  • In-depth understanding of current global regulatory expectations, such as 21CFR Parts 210 & 211 and 21CFR part11
  • Lead the CAPA process, ensuring CAPA is implemented in a manner that is both efficient and timely
  • Assist engineering or other functional groups in prototype development, evaluation and documentation
  • Guides implementation of new standardization projects at T1 facilities
8

Responsibilities For Manager, Quality Systems Footwear Resume

  • In collaboration with Operation Managers and Senior Quality Manager, certifies T1 QIP Final Inspectors (FI) and FINAL Inspectors
  • Documents new formulas. Monitors operation of rubber, EVA and injection plastics processes, compounding formulas, curing times and physical properties of materials to maintain adidas-Group quality standards
  • Identify non conformances as it pertains to CAPA’s and provides guidance to resolve
  • Continually develop, monitor and report on the metrics needed to gauge the performance of the Quality Management System
  • Sustain and continually improve the WITS ISO 13485 Management System – manage the relationship with the Notified Body
  • Liaise with the regional and global Q&RA organization to support the development of and ensure alignment with BEC global policies and procedures
9

Responsibilities For Manager, Quality Systems Operations Resume

  • Work on complex issues where analysis of situations or data requires an in-depth evaluation of various factors
  • Perform as a Role Model Leader, acting in compliance with the Thermo Fisher Code of Ethics Administer the Division’s overall Quality System, management of the Company’s Quality Assurance and Quality Control departments, assuring that all Company policies and practices meet or exceed all regulatory requirements
  • Quality systems demonstrated knowledge in areas such as document management, document change control audits, batch record and label issuance
  • Experience with direct management of employees
  • Experience in the medical device domain required
10

Responsibilities For Manager, Quality Systems Document Control Resume

  • Proficient in MS Word, Excel, Power Point, Adobe Pro, and electronic document management systems (Document Locator, documentum, Veeva or equivalent)
  • Leadership and coordination of Quality System Processes implementation and maintenance at Amgen Woburn
  • Leadership and coordination of the Site Quality Management Review
  • Represent Amgen Woburn and negotiating and influencing Corporate and other site’s Quality System Leads towards simple, effective, compliance processes that meet Regulatory Expectations
  • Participate in regulatory inspections, as necessary, representing Amgen’s Quality System and Processes

Related to Manager, Quality Systems Resume Samples

Quality Systems Resume Sample

Work Experience

  •  Conceptualize, reason through problems, make effective decisions and develop alternative solution and provide excellent customer service while ensuring compliance with the American Heart Association’s policies and procedures   •  Prepares written documents describing analysis techniques and test resul...
Professional Skills

  •  Excellent written, verbal and presentation...
  •  Demonstrated teaming skills, including the...
  •  Strong computer skills with ability to rap...
4.7
19 votes

Quality Systems Analyst Resume Sample

Work Experience

  •  Analyze complaint, investigation and repair data for trends and make appropriate recommendations for design improvements, process changes or customer communications   •  Administrate the internal audit program ensuring all action items and internal audit program activities are performed in a timely ma...
Professional Skills

  •  Defines complex issues; recommends and gui...
  •  Strong organizational skills, task oriente...
  •  Proven ability to apply strong analytical ...
5.0
18 votes

Quality Systems Manager Resume Sample

Work Experience

  •  Domestic and international travel of 10-15% is required   •  Maintain the smooth operation of the DUSM quality systems, following established GMP’s, HACCP procedures and the ISO Quality System   •  Lead the development, maintenance and deployment of the Quality Manual, corporate SO...
Professional Skills

  •  Excellent high level oral & written commun...
  •  Proven managerial/leadership skills such a...
  •  Strong leadership and shaping skills (Infl...
4.5
21 votes

Senior Testing Resume Sample

Work Experience

  •  Proactively report critical issues and risks to management   •  Update changes and maintain all documentation related to the manual / automated testing process   •  Coordinate the test set-up for all assigned projects including environments, change control, and pre-defined data &nb...
Professional Skills

  •  Proven ability to diagnostic and problem s...
  •  Good oral and written communication skills...
  •  Superior management skills and supervisory...
4.7
13 votes

Lead, Quality Control Resume Sample

Work Experience

  •  Team members, Managers, and other departments to partner in the delivery of key accountabilities   •  Internal business partners across operating groups to consult/advise/service in the delivery of key accountabilities   •  Maintains Good Drivers Safety Record: Maintain a valid dri...
Professional Skills

  •  Strong troubleshooting skills to understan...
  •  Two to 3 years’ experience independently r...
  •  Experience with Aerosol testing and medica...
5.0
7 votes

Software Quality Engineering Resume Sample

Work Experience

  •  Monitor SQE’s tasks and progress, reviewing games under development for technical risks, providing mitigation plans where/if possible and managing quality   •  Work with Software Department Leadership to define and report relevant metrics   •  Research and implement state-of-the-ar...
Professional Skills

  •  Excellent verbal and written communication...
  •  Strong interpersonal communication skills ...
  •  Good written and oral communication skills...
4.7
17 votes
Resume Builder

Create a Resume in Minutes with Professional Resume Templates