Quality Director Resume Sample
Roslyn Veum
332 Vita Freeway,
Detroit,
MI
+1 (555) 768 2068
Work Experience
Quality Director
12/2017
-
PRESENT
Philadelphia, PA
- Monitor business performance and ways of working to identify potential problem/improvement areas
- Have the authority to initiate RCA investigations on problems and issues deemed significant regards the wanted Excellence and Quality
- Lead and support quality related escalations or incident from region CU or customer
- Execute or mange the execution of these RC investigations and identify needed corrective / improvement actions – Assign these actions to owners and if needed initiate and manage GSC wide improvement programs
- Review and drive progress to ensure timely and effective implementation of actions
- Foster a spirit of continual improvement and willingness to alert of issues and drive for improvement
- Provide leadership to strive for ongoing excellence and quality improvement and be a champion for any needed change
Senior Quality Director
11/2010
-
07/2017
Los Angeles, CA
- Facilitate, participate, review, lead and/or approve Investigations, root cause analysis Change controls, complaints, etc
- Quality Management experience within manufacturing type of company
- Experience in keeping good relationships with customers and suppliers
- CI, Lean Manufacturing, Six Sigma methodology experience, Six Sigma Black Belt would be an asset
- Computer Literate (MS Office/Project/Visio, Minitab)
- Problem Solving concepts (8D, A3, Root Cause Analysis etc.)
- ISO9001/ISO Standards knowledge as well as auditing knowledge
- Manage the implementation of the quality management system
- Serve as company Management Representative, to ensure that quality management system requirements are effectively established and maintained in accordance with medical device regulations and international standards
Quality Director, Data Integrity Leader
09/2005
-
05/2010
Philadelphia, PA
- Lead the development and execution of quality policy, quality objectives, and strategic quality plans
- Serve as Authorized Representative liaison in the EU, providing support in areas of complaint handling and technical documentation
- Serve as lead Spiration contact for inspections by regulatory agencies
- Coordinate preparation activities and ensure the company maintains a state of readiness for inspections
- Represent the Quality function on project teams, providing quality and regulatory compliance input, feedback, and guidance
- Review and approve product and manufacturing changes via Document Change Notice (DCN) approval to ensure adherence to quality system requirements
- As an alternate to the Director of Regulatory Affairs, assess the impact of changes on current clinical investigations and FDA filings
- Review device labeling and advertising materials for compliance with US and international labeling regulations
Education
University of Wisconsin-Richland
2000 - 2005
Engineer's Degree in Engineering
Professional Skills
- Develop and execute a Quality Plan aligned to the strategic direction of Teradata. Establish an analytical data driven approach to determine software quality. Manage the tracking and trending of product performance and quality indicators and make improvements and adjustments as required
- Demonstrated effective interpersonal, teamwork, networking skills, collaboration, negotiation & conflict resolution skills
- Demonstrated strong leadership and people management skills and experience
- Multi-task, with strong organizational skills and ability to prioritize
- Experience authoring or approving validation protocols, Non-conformities, Change Requests, SOPs, Validation Plans and Reports is required
- High-level problem solving skills and management experience in a highly regulated manufacturing environment
- Demonstrated troubleshooting, analytical, and planning skills
How to write Quality Director Resume
Quality Director role is responsible for interpersonal, analytical, leadership, negotiation, presentation, manufacturing, training, customer, organization, reporting.
To write great resume for quality director job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Quality Director Resume
The section contact information is important in your quality director 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
- Telephone number
Work Experience in Your Quality Director Resume
The section work experience is an essential part of your quality director 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 quality director responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular quality director position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Quality Director resume experience can include:
- Develop systems, implement and train employees on quality and regulatory requirements in areas including, but not limited to, management review; corrective and preventive actions; internal quality audits; post market surveillance/complaints; and recall/removals. Activities include the following
- Effective communication and strong presentation skills
- Proven history of driving process improvements. Process excellence experience and experience leading change management projects
- Excellent organizational, leadership, human relations and communications skills
- Excellent organisational, communication, interpersonal and customer relationship skills
- Strong Excel, Access, MS Word, Power Point, skills required
Education on a Quality Director Resume
Make sure to make education a priority on your quality director resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your quality director 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 Quality Director Resume
When listing skills on your quality director 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 quality director skills:
- A collaborator who listens effectively and invites response and discussion. Possess good negotiation skills and excellent communication skills
- Possesses excellent leadership and organizational skills with prior experience leading managers, engineers, technicians, and operators
- Excellent interpersonal skills with the ability to communicate effectively both verbally and written
- Highly effective communication skills, including interactive listening with proven ability to negotiate across all levels of the organization
- Can communicate effectively by using written and oral skills
- Proven strong oral and written communication and presentation skills
List of Typical Experience For a Quality Director Resume
1
Experience For Senior Quality Director Resume
- Proven record of lean manufacturing skills and experience
- Experience in facility, equipment and cleaning commissioning/qualification/validation
- Experience in facility, equipment and cleaning commissioning/ qualification/ validation
- Related work experience gained from an Engineering or Manufacturing environment. Automotive experience is desirable but not essential
- Proven experience managing employees across a global team
- Solves problems in complicated situations using analytical skills, creativity, and judgment
- Read, analyze, and interpret common and technical information and translate it effectively to other areas of the company
2
Experience For Customer Quality Director Resume
- Develop approach to enhance Quality within the plant, through training awareness and development of skills both of the Quality team and wider organisation
- Extensive Quality/manufacturing experience in commercial drug product manufacturing organisations (preferably acted as QP)
- Experience leading/managing a large, complex and geographically-dispersed team
- Experienced in the quality oversight of drug product manufacture and analytical testing
- Capable of forming strong professional relationships across all functional lines and gain the respect of those in partner lines
- Experience delivering complex projects on time in budget
3
Experience For Quality Director, Data Integrity Leader Resume
- Experience in Manufacturing Quality Control/ Quality assurance/Senior Management /Senior position
- Ensure Quality Operating System are robust, effective, and executed in all plants
- Plan department budgets and manage expenses. Establish project priorities and allocate resources according to workload
- Strong communicator both upward and to lower levels of the organization
- Defines problems, collects data, establishes facts, and draws valid conclusions
- Experience of front line regulatory interaction (e.g. HPRA, FDA, MHRA)
- Experience in “right first time” and continuous improvement philosophies
4
Experience For Retiree Solutions Quality Director Resume
- Practical first-hand experience in either: drug product manufacture, analytics or quality management
- Experience of front line regulatory interaction (e.g. OGYEI, MHRA)
- Excellent knowledge of English and Hungarian
- Management of internal audit, ensuring effective corrective actions
- Proven ability to design and assist in the timely delivery of high-quality software
- Check the effectiveness of the corrective actions to the NC findings by the TS certificate body
- Overall responsibility for Quality, Validation, Clinical quality activities
5
Experience For Regional Quality Director Resume
- Over 10 years' experience in a leading role in the pharma industry
- Strong ability to embrace change, see the big picture and set strategy to drill down company and team initiatives
- Experience with start-up / medium size pharma companies is an advantage
- Responsible for ensuring that systems in-scope are maintained/remediated in a validated state across all segments and regions globally
- Ensuring FAA compliance, including participation in regular MIDO meetings
- Providing QMS training to all ACSS employees
- Working to minimal direction
- Ensuring L3 Corporate compliance
- Ensuring quality and regulatory compliance
6
Experience For Clinical Lab Quality Director Resume
- Outsourcing/foreign development and production collaboration
- Working with x-functional operational Quality groups to deliver NPI and post launch/product robustness projects
- Manage Group Quality Managers team including development, coaching, training, etc
- Responsible for operation excellence and benchmarking, learning and sharing knowledge
- Exercises common sense in decision making and exercises discretion while managing confidential information
- Provide solutions using interpretive, creative and innovative thinking
- Background in auditing suppliers with emphasis on Heat Treat & Plating processes
- Support hiring, development, and succession planning activities for all NA plants
- Manage problem solving activities using QRQC method
7
Experience For Corporate Quality Director Resume
- Financial responsibilities include total quality department overhead spending and capital budgeting and expenditures
- Manage product complaint handling system
- Oversee the implementation of applicable post market activities. Post market studies are conducted in conjunction with Clinical Affairs and Marketing
- Proficient in Word Processing software, Spreadsheet software, Development software, Design software, and Internet software
- Oversee the QC function, ensuring adequate procedures and full data integrity in all laboratory operations, and a robust talent pipeline in the QC organization
- Direct a multi-dimensional approach to quality activities during prototype and production stages as defined in the APQP
- Lead cross-functional quality review, training and issue resolution meetings
- Monitor and define quality policies, manual and procedures while ensuring compliance to the quality system requirements
- Facilitate and lead continuous improvement projects, leveraging global best practices to drive best in class processes
8
Experience For Quality Director Home Health & Hospice Resume
- Own quality KPI reporting and improvement
- Knowledge of production control, material management, purchasing, Quality and R&D
- Support North American plants in achieving quality performance metrics
- Facilitate sharing of best practices, lessons learned, and other quality related read across items to all plants globally
- Work with outside third-party consultants as needed for implementing company quality procedures
- Serve as primary liaison on Life Science Counsel in addressing regulatory issues, quality coordination, and company quality requirements for delivery
- Apply total quality management tools and approaches to analytical and reporting processes
- Design, develop and implement quality control training programs
9
Experience For Tax Practice Policy & Quality Director Resume
- Manage and motivate the QA and QC teams to deliver their goals and objectives, including talent development and inferior performance
- Works across multiple product lines and types of manufacturing processes seamlessly
- Provides training, mentors, and coaches team members and peers
- Manage activities of cross-functional teams to support and deliver solutions relating to total quality
- Responsible for quality talent management, development program and participate in goal setting and performance appraisals across BU
- Responsible for quality talent management, development program and accountable for executing the specified quality and business strategic initiatives
- Contain issues in house and at customer after having defined level of exposure
10
Experience For Regional Quality Director, CCS Resume
- Administer and provide ongoing continuous improvement and implementation of the quality assurance and quality control program
- Responsible for understanding customer needs and requirements
- Responsible for driving innovation
- Create and revise quality system procedures, as required
- Chair and coordinate quality management review meetings. Oversee action items associated with meetings, including actions associated with trending presented in meetings
- Ensure completion of all corrective actions associated with the quality system and ensure that the CAPA process is in compliance with regulatory requirements
- Perform internal quality audits according to the approved schedule. Manage audit processes including managing audit resources, tracking status of audit findings to closure, and audit record retention
- Assist Regulatory Affairs with filings of Vigilance reports and MDRs when required
List of Typical Skills For a Quality Director Resume
1
Skills For Senior Quality Director Resume
- Strong QA analyst skills with experience in Computerized System Validation in GxP environments in the pharmaceutical/medical devices industry required
- Excellent leadership skills with demonstrated ability to influence senior leadership
- Strong communication skills, Excellent in presentation
- Strong interpersonal skills, including the ability to deliver presentations to all levels of the organization
- Knowledge and experience in statistics preferably good experience in Six Sigma / Lean
- Strong influencer who can effectively communicate at all levels of the organization
- Excellent analytical, communication, managerial and leadership skills
2
Skills For Customer Quality Director Resume
- Strong leadership, communication and interpersonal skills with ability to interact with all levels of employees and customers
- Excellent analytical and reasoning ability for solving problems and good judgment for decision-making
- Experience in running large scale end-to-end Validation programs like LIMS, CAPA, MES, PLM, SAP, LMS and Complaints Handling
- Capable of quickly demonstrating influencing skills and abilities
- Proven experience leading and managing regulatory inspections with Global Authorities and notified bodies
- Experience in running Global Validation programs along with Global teams across multiple geographies
3
Skills For Quality Director, Data Integrity Leader Resume
- Above 15 Years' working experiences in the field of auto parts .At least 10 Years' experience in quality management
- Root cause analysis/problem solving skills
- Demonstrated experience as a change agent in driving a cultural shift from inspection based systems to more proactive, process focused environment
- Solid experience with leading a team of direct reports
- Demonstrated knowledge of International Quality and Compliance standards and requirements, with preferable FDA experience
- Experience in senior management position/3+ years’ experience in director position is desired
- Hospital Quality Director experience required; 3 or more years. Previous clinical experience in an acute care setting
- Clinical/business analytical skills with the ability to link information to action and results
- Proficiency in computer skills, Microsoft Office (Windows, Outlook, Excel) & Sunrise applications with the ability to learn new applications
4
Skills For Retiree Solutions Quality Director Resume
- Evidence of experience in successful leadership of organizational quality management programs
- Evidence of experience in successful performance improvement and/or project management
- Strong working knowledge and experience as a BIQS auditor
- Tactical management and people skills are required and applied in the supervision of employees and negotiation with company's employees in other departments
- Proven organizational and cultural change management experience
- Detailed-oriented, self-motivated, positive, strong sense of responsibility and a good team player
- Working knowledge of the company's products or similar Working knowledge of the ISO 9000 and AS 9100 standards Previous leadership experience
5
Skills For Regional Quality Director Resume
- Supervisory and management experience including hiring staff, coaching, performance management daily operations supervision, discipline and counseling
- Experience in leading or participating in a successful process improvement effort using the CMMI® in multiple organizations
- Experience successfully implementing CMMI processes resulting in a CMMI Level 3 rating
- Experience managing FDA site inspections and teaming with customer and business partners to start up new medical product manufacturing projects helpful
- Extensive experience in managing and developing high performing teams
6
Skills For Clinical Lab Quality Director Resume
- Experience leading, mentoring, and building teams
- Strong background in developing and monitoring quality performance metrics – and using such data to implement significant improvements
- Lead and manage teams by Assigning activities according to the company objectives, priorities and regulatory requirements
- Experience working with suppliers, leading supply chain quality improvement efforts
- Experience of at least 10 years in manufacturing preferably gained in a similar industry or similar demanding industry
- Experience in interacting with regulatory agencies, notified bodies and multi-national manufacturing companies
- Experience working and communicating with all levels of management and individual contributors within the organization
7
Skills For Corporate Quality Director Resume
- 5) Experience with writing and implementing quality policies and procedures; and
- Lead effective corrective action using disciplined problem solving methods and statistical analysis
- Project/program management experience and deep understanding of automotive product development gates, timing, and processes
- Experience managing quality functions within medical capital equipment manufacturing and service
- Strong planning and organizing
8
Skills For Quality Director Home Health & Hospice Resume
- · Strong working knowledge of ISO Quality Management Systems Standards
- Experience working in multi-site matrix organization
- Relevant work experience in a World Class Manufacturing environment
- Good understanding of CE and RI&E and certification systems (for example ISO, TQM, etc.)
- Experience implementing ISO 9001 organizational processes and Quality Management Systems
- Knowledge and experience using Microsoft SharePoint
- +10 years of experience in the related field in an automotive manufacturing environment
- 2) Experience with root cause analysis, corrective action systems, process mapping, laboratory methods
9
Skills For Tax Practice Policy & Quality Director Resume
- 3) Experience in food safety and environmental monitoring
- Good understanding of company’s policies and processes
- Leadership experience with working knowledge of Joint Commission Standards, State and Federal regulations, and professional standards and practice issues
- Experience in a leadership position within a Quality Assurance/ Food Safety/ Regulatory environment within the Food and/or Flavor manufacturing industry
- Experience in leading a successful Partial Hospitalization Program and Intensive Inpatient Program
- Experience in a Quality role working with National Quality Stakeholder Organizations
- Experience with injection molding for medical device and medical device manufactures
10
Skills For Regional Quality Director, CCS Resume
- Experience working under clean room conditions, sterilization and environmental control conditions preferable
- Quality related working experience in Auto Industry
- Develop and maintain an effective working partnership with senior management
- Ensure corporate priorities and strategies as deployed taking into account SP site’s needs
- Operations/quality experience leading large teams
- Experience with Advanced Product Quality Planning (APQP)
- Experience in applying measurement and statistical process control techniques
List of Typical Responsibilities For a Quality Director Resume
1
Responsibilities For Senior Quality Director Resume
- Excellent verbal, written, and presentation communications skills.
- Excellent interpersonal skill and the ability to influence peers and functional leaders within ACSS
- Two years of experience in Quality Assurance, Internal auditing, or Accounting in a health care or production based environment
- Provides administrative, technical, education and coordinating support to ensure effective, timely quality management activities
- Process improvement experience, knowledge of continuous improvement methodologies & in depth understanding of related processes
- Two (2) years of MMIS or government, or private sector healthcare payer experience
- Reviewing customer requirements and ensuring that they are met including following up on customer returns
- Working with purchasing staff to establish quality requirements from external suppliers and ensuring that these are fully adhered to by the suppliers
2
Responsibilities For Customer Quality Director Resume
- Maintain quality assurance staff job results by coaching, counseling, and disciplining employees; planning, monitoring, and appraising job results
- Act as Subject Matter Expert in analyzing data and using CAPA on KKM, while demonstrating robust root cause analysis
- Assists with compiling quarterly report for Board and Medical Staff regarding performance improvement reporting
- Conducts meeting with various departmental leaders to review data relating to identification and evaluation of performance improvement activities
- Lead the Quality assurance objectives in a manufacturing excellence, continuous improvement environment, implementing best practices
3
Responsibilities For Quality Director, Data Integrity Leader Resume
- Familiarity with Agile development methodologies, including SCRUM and KANBAN
- Responsible for regional quality support to manufacturing plants in the Greater China
- Support the regional quality head to handle the Group quality requirements, and pursue the corresponding tasks
- Provide Lean Six-sigma training for green belt & black belt
- Have competence in understanding the international quality management system
- Take the leading role of the QP in the organisation
4
Responsibilities For Retiree Solutions Quality Director Resume
- Ensure all products manufactured direct an directly are meeting all standards and compliance
- Work with the QA Managers to evaluate/improve workflow, division of responsibilities, and create a resource development plan to support continuing growth
- Ensures contractual and quality assurance daily, weekly, monthly, and yearly reporting requirements are developed, met, and maintained
- Conducts various types of analyses including data, feasibility, technical, and workflow processes
- Perseverance – Pursues everything with energy, drive and a need to finish; seldom gives up even in the face of resistance or setbacks
- Participates in the aggregation, analysis of OPPE and FPPE as well as entering quality data in physician performance profiles for reappointment
- Strengthen quality leadership through collaborations with the HERE Quality
- Develop organization-wide programs to raise employee awareness of the company's quality objectives and voice of the customers
5
Responsibilities For Regional Quality Director Resume
- Champion, monitor and advise on the business management system performance, reviewing performance data against system standards for continuous improvement – while maintaining constant awareness of business context and company profitability
- Establish and execute an internal audit program that includes facilitating robust root cause analysis and systemic solutions for areas of non-conformance or opportunities for improvement
- Facilitate internal/external ISO 9001 audits, A-SPICE assessments and other QMS standards
- Establish quality and reliability standards by studying product and customer requirements with other members of management and product teams to enable meeting and exceeding customer expectations
- Support organization through review of customer requirements, RFQs and other quality requirements to determine feasibility and attainment
- Travel up to 30%, mainly to our office in Chicago, US
- Six Sigma, Lean, FMEA, 8D and CSQE certification desirable
- Practical knowledge in the evaluation and application of business Key Performance Indicators (KPIs) and Critical Success Factors (CSFs)
- Regularly review APQP of the important new projects of the plants, and follow up the actions
6
Responsibilities For Clinical Lab Quality Director Resume
- Regularly review the plants monthly QM reports and the KPIs, request improvement actions if needed
- Perform the Internal System audits of the plants, follow up the NC corrective actions
- Support the important customer visits / audits of the plants, follow up the corrective actions
- Support supplier quality management of the plants per requests of the plants, follow up the actions
- Manage the strategy and development plans for all Quality functions
- Oversee the global GxP, QMS and quality programs
- Responsible for success of internal and external audits
7
Responsibilities For Corporate Quality Director Resume
- Ensure sufficient compliance and standards are met for all government regulations globally
- Act as the key contact for all product quality related issues within and outside the organisation
- Work closely with supply chain to establish continuous improvement initiatives with supply partners, including establishing supply agreements in conjunction with Supply Chain Operations, Legal, Sales and Marketing peers
- In-depth knowledge of all relevant clinical, GxP and Quality Systems requirements in the US, EU, ISO, and MDD
- Working closely with data quality technical staff, applications developers, and the data owners/subject matter experts from the businesses to advance Risk’s objectives
- Responsible for directing regional Q-CSV staff
- Responsible for implementing and execution of IT Quality processes in alignment with IT Quality goals and objectives
- Responsible for conducting risk based regional IT Quality and Compliance checks and remediating compliance risk identified through periodic reviews and audits/inspections
8
Responsibilities For Quality Director Home Health & Hospice Resume
- Responsible for identifying potential gaps with in-scope systems, raise appropriate Non-Conformance, CAPA and drive remediation with business and IT alignment
- Responsible for ensuring execution of streamlined infrastructural regional IT Quality support activities such as onboarding of new hires, inspection support, monitoring of local regulatory intelligence and maintaining local SOPs
- Responsible for monitoring the timely development and maintenance of GXP systems and describing mitigation and remediation actions to address (potential) risk for the regions/country
- Responsible for participating and influence decision making in Steering Committees, System Advisory Boards, Change Advisory Boards and other relevant forums
- Responsible for managing Program/Department budgets
9
Responsibilities For Tax Practice Policy & Quality Director Resume
- Responsible for providing guidance to regional IT Quality staff in collaboration with global IT Q-CSV leaders
- Responsible for providing CSV guidance and support to project and/or base business support teams
- Responsible for building and maintaining trusting, collaborative relationships and partnerships with internal and external stakeholders which help accomplish key business objectives, and helps others to do the same
- Responsible for facilitating and communicate key messages and presentations to various cross-functional groups to gain support
- Responsible for implementing standards to move the organization toward a more positive risk management posture by utilizing extensive knowledge of current and emerging best practices in risk management
10
Responsibilities For Regional Quality Director, CCS Resume
- Responsible for providing an environment which encourages the company's credo, commitment to equal employment opportunity and the value of a diverse work force
- Ensure that campaign reports are appropriately managed and used to define the following year’s improvement action plans
- Makes decisions on technical issues and approaches to projects with supervisory and staff input regarding resource allocation and time schedules
- Direct line access and reporting to the ACSS President, per the FAA-approved Quality Manual
- All ACSS process compliance assurance, encompassing all functions within ACSS
- Ensure senior Q-CSV business leadership receives periodic updates on compliance of systems in scope for the region
- Mentor talent and help associates grow in their careers
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