Quality System Resume Sample

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Taurean Beer
7411 Lowe Parkway,  Detroit, MI
+1 (555) 453 1604

Work Experience

Quality System Specialist
03/2018 - PRESENT
Detroit, MI
  • Performing tasks, of moderate complexity, within planned schedules and timelines, supporting audits, actively leading or participating on project teams, ensuring documentation compliance, and handling customer complaint investigation/resolution
  • Provides the Medical reviews and approval FDA Adverse Event Reporting Review and Research Product Safety Review Decision Trees
  • Support device investigations through thorough reviews to ensure consistency and correctness, in addition to reportable reassessment
  • Perform statistical analysis, including comparison and contrast of trends and results against goals. Supports Reports and Daily, Monthly, Quarterly and Management Reviews based on the data analysis
  • Conducts evaluations on all plant level customer complaints. This includes documentation review, samples testing and root cause analysis as necessary
  • Trends complaint data using statistical techniques to identify significant changes and proactively initiates programs to reduce customer complaints. Identify chronic complaint categories requiring investigation
  • Actively participates in monthly Corrective Action Board/Continuous Improvement Committee (CAB/CIC) meetings and provide feedback as pertaining to Continuous Improvements
  • Assists Quality Assurance personnel in addressing quality issues, as appropriate
Quality System Coordinator
07/2013 - 11/2017
Phoenix, AZ
  • Represent Promega in discussions/interactions with partners, vendors or customers, as requested
  • Represent Promega in external audits, as requested
  • Work with management on urgent/critical activities or actions needed for the business
  • Conduct supplier audits of suppliers or partners
  • Direct staff to ensure that Quality Systems are maintained in compliance with Health Authorities, current Good Manufacturing Practices (cGMPs) and Roche policies and procedures
  • Ensure maintenance and continuous improvement of Pharma Quality Systems processes. Establish and maintain Quality Strategy, Quality Master Plan, and TCM for Quality Assurance. Facilitate and coordinates Quality System Management Review for assigned site (e.g., Site Quality Council)
  • Oversee Risk Management and provide relevant tools and expertise. Ensure potential product and patient risks are systematically assessed, controlled, reviewed and communicated, and that risk management activities are documented appropriately
  • Oversee and guide Document Center / Records and Document Change Management systems and processes
Quality System & Data Support Intern
04/2007 - 02/2013
New York, NY
  • Conducts quality training as required to ensure compliance with Federal Regulations and International Standards where appropriate. Responsible for Quality Awareness and Good Manufacturing Practices training at all employee levels
  • Works with other departments to maintain the highest quality standards
  • Complies with, and responsible for enforcing, all local, state, federal and BD safety regulations, policies/procedures
  • Observes all safety, environmental and quality system standards
  • Proficient with other Microsoft office tools (Word, Outlook, PowerPoint)
  • Basic quality systems regulation knowledge
  • Strong verbal, written, analytical, communication and interpersonal skills


Brown University
2002 - 2007
Bachelor's Degree in Engineering

Professional Skills

  • Strong organizational skills and demonstrated ability to meet tight deadlines in an environment of competing priorities
  • Demonstrated strong organizational, interpersonal, influencing, communication, and leadership skills are an asset
  • Strong presentation, analytical and customer service skills with a proven track record in Quality Management
  • Understanding of quality science, clinical usage of devices, knowledge of quality systems, and strong performance management skills
  • Excellent Critical Thinking skills and ability to adapt to a constantly changing and rapidly growing environment
  • Strong analytical, deductive reasoning and listening skills
  • Good communication skills to effectively present information both orally and in writing to diverse groups

How to write Quality System Resume

Quality System role is responsible for computer, analytical, interpersonal, leadership, presentation, database, microsoft, training, software, organizational.
To write great resume for quality system job, your resume must include:

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

Contact Information For Quality System Resume

The section contact information is important in your quality system 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 Quality System Resume

The section work experience is an essential part of your quality system 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 system 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 system position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions. Representative Quality System resume experience can include:

  • Strong presentation skills, strong teamwork and team building skills, strong leadership skills
  • Very good communication, presentation and teamwork skills with a proven ability to deliver results
  • Strong skills in analytical thinking and problem solving
  • Good communication skills at all levels, both written and verbal; both individually and in a group setting
  • Good decision making skills. Ability to make decisions with limited information
  • Strong team-building skills, with the ability to function as a team player

Education on a Quality System Resume

Make sure to make education a priority on your quality system resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your quality system 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 System Resume

When listing skills on your quality system 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 system skills:

  • Strong training skills with experience developing, delivering and evaluating training effectiveness
  • Strong interpersonal and listening skills and the ability to effectively interact with all levels of LMI personnel and vendors in a professional manner
  • Knowledge of relevant PC software applications and skills to use them effectively
  • Demonstrate strong organizational, communication, and collaboration skills
  • Good proofreading, editing, and technical writing skills
  • Effective skills in analytical thinking and problem solving require

List of Typical Experience For a Quality System Resume


Experience For Quality System Specialist Resume

  • Practical experience with GMP documentation and writing skills in FDA regulated environment
  • Demonstrate a solid understanding of the customer focused strategy
  • Partner effectively with all levels of the organization to drive results, proactively identify and resolve problems, manage conflicts and escalate as required
  • Experience with GxP Quality Systems, including but not limited to investigations, qualifications, validations, CAPA, and NC
  • Experience in writing procedures (i.e. Standard Operating Procedures, test protocols, reports, etc.)

Experience For Quality System Manager Resume

  • Experience in working in the electronics manufacturing industry is highly appreciated
  • Relevant experience in complaint handling, quality or regulatory field
  • Experience in working in the automotive industry is appreciated
  • Strong Knowledge in quality system
  • Reviews ISO TS-16949 / IATF 16949 documentation for adequacy prior to release
  • Strong Leadership style in order to motivate employee to improve quality systems
  • Strong knowledge in standards such as AIAG and ISO standards or similar
  • Medical Device industry experience 3-5 years

Experience For Quality System Coordinator Resume

  • Strong working relationship with internal and external customers
  • Experience of mechanical relevant products with working in a cross functional team environment
  • Experience with medical terminology, clinical or laboratory knowledge and familiarity with BD products
  • To input into the development and maintenance of a global healthcare change management system and effective implementation at a local level
  • Establishes a good quality of work

Experience For Senior Quality System Specialist Resume

  • Pharmaceutical or Nutraceutical documentation experience
  • Maintain a strong attendance record
  • Knowledge and application of Good Manufacturing Practices (GMP). Knowledge of applicable procedures, specifications, regulations and standards
  • Experience of pharma, medical device, consumer or related industries
  • Experience in Quality Assurance, process improvement, or related function
  • Prioritize work based upon communications with internal customers along with departmental goals and objectives

Experience For Quality System Analyst Resume

  • Creating, maintaining and updating Quality System documentation including coordination of the documentation workspaces usage
  • Ensuring implementation of CGI’s Quality Management system with tailoring specific to Finanssi-Kontio
  • Coordinating external and internal audits regarding ISO9001, ISO27001 and SOX compliance
  • Conducting quality orientation/refresher training for staff
  • Training the quality management system to the organization in Finland
  • Collaborating tightly with business units to proactively mitigate quality deviations in projects and application management services

Experience For Senior Quality System Analyst Resume

  • Implementing IMS National and Regional Annual Work-plan at the local level
  • Maintaining the QMS documentation
  • Routing the complaint to appropriate location for further evaluation
  • Checking for complaint accuracy and content, correct information to process the complaint
  • Handling of product complaint/FCA’s
  • Acting as a central contact point regarding quality assurance and process development

Experience For Quality System Leader Resume

  • Working closely with your colleague team members in India
  • Conducting audits and act in the role as Lead Internal Auditor
  • Analyzing data and present “data that matters” to process owners and other internal clients
  • Driving Continuous Improvement (CI) initiatives within defined portfolio; and,
  • Participating in CI projects at the Regional and National Level
  • Provide training oversight for the site quality department concerning the GMP training and Quality Systems-related training
  • English – language capability, speaking, reading and writing required

Experience For Quality System Supervisor Resume

  • Review electronic documents submitted to document control for correct formatting, spelling and clarity of text before releasing as approved documents
  • Responsible for determining non-conforming products and materials disposition (implementing QA quarantines and/or release of affected inventory)
  • Monthly reporting to the QMS Steering Committee
  • Define a lean training and training administration practice in scope
  • Ensure the assignment of training requirements profiles and documentation for all job’ required training
  • Report on training compliance and training related KPIs
  • Support users on using the Training Management System
  • Provides compliance support for manufacturing, R&D, Quality Assurance, and Operations to assure regulatory compliance and appropriate business planning
  • Provide internal guidance and education regarding customer complaint processing, MDRs, and regulatory compliance

Experience For Quality Shop Director & Quality System Manager Global Propulsion Systems Resume

  • Responsible for formatting, proper spelling and clarity of text for any written documents submitted to document control
  • Monitor customer feedback to manage complaint process, including assisting in the determination of reportability to regulatory authorities
  • Files GMP records including, but not limited, batch records, purchase orders, complaint records, training records, etc
  • Facilitate working groups according to identified needs relative to QDMS and follow up planned actions
  • Encourages problem-solving processes leading to leveragability of solutions across divisions
  • Provide training to new employees on ISO9000 basic concepts according to HR guide
  • Other activities such as training, coaching, and committees participation that the department could need
  • Presents information concerning the status and progress of quality systems to plant management and personnel
  • Coordinates with third part auditor and customers concerning registration activities

Experience For Senior Quality System Manager Resume

  • Directs the execution and performance of the company's QMS activities. This include establishing the ISO certification
  • Provides clear guidance for this area and the company overall by ensuring clear policies, procedures, instructions, forms & objectives are provided
  • Plan and monitor the training of people in the QMS team
  • Knowledgeable in current standards and regulations, including QSR and ISO13485:2003
  • Drive to resolve these issues completely and with speed by leveraging your network of key contacts outside your own area of expertise
  • Identifies and implements corrective actions as required to ensure adherence to policies, procedures and working instructions
  • Provides regular program status reporting and recommendations to Senior Management

List of Typical Skills For a Quality System Resume


Skills For Quality System Specialist Resume

  • Capable of both written and verbal effective communication skills in English and in french including presentations as assigned
  • Good interpersonal skills with the ability to resolve problematic issues quickly and efficiently
  • Quality systems and operational skills and experience
  • Good time mangement skills, detail-oriented, well organized and able to multi-task
  • Strong interpersonal, organizational and service orientation skills
  • Strong communication skills (verbal, written) and an ability to interact with people at different levels of the organization

Skills For Quality System Manager Resume

  • Excellent interpersonal skills to interact with cross-functional groups and leadership
  • Good communication skills both oral and reading
  • Effectively manage change and comfortable changing direction and acting without complete information
  • Collaboration and Teaming including cross-functional teams, negotiates and resolves conflicts effectively
  • Effectively complete quality system training

Skills For Quality System Coordinator Resume

  • Recommend and drive items to demonstrate training effectiveness improvements
  • Manage multiple priorities and demonstrate independent and strategic thinking
  • Effectively communicate both orally and in writing to staff, management, customers and regulatory personnel
  • Effectively communicate both orally and in writing to management, customers and regulatory personnel
  • Experience working in a regulated environment. Experience required in a device or pharma Quality/Regulatory environment
  • BS in an engineering discipline with 3-5 years of technical experience OR MS/ME with 2-3 years of technical experience
  • Applies Good Manufacturing Principles and Good Documentation Practices in all areas of responsibility

Skills For Senior Quality System Specialist Resume

  • Experience with GxP Quality Systems, including but not limited to investigations, qualifications, validations, CAPA, and NC is also required
  • Technical Learning – can learn new skills and knowledge quickly
  • Strong ability to manage and work with different cultures and nationalities, experience working in complex global environment
  • Excellent working knowledge of medical device regulations (21CFR), ISO 13485, Medical Device Directive, Good knowledge of FD&C law
  • Computer literate, (advanced word processing skills; competent in spreadsheet and database applications; comfortable in networked environment)
  • Able to communicate diplomatically and effectively (both verbally and in writing)

Skills For Quality System Analyst Resume

  • Computer skills (Excel, Word, Power Point, etc.)
  • Computer skills including knowledge of Windows, Word, Excel, Documentum, SAP, and database programs
  • Work effectively in a diverse and changing work environment
  • Able to use product/functional expertise and project/team leadership skills to meet customer driven dates and milestone
  • Manages, trains and develops the Quality Department staff to effectively support the Quality System
  • Strong experience with Microsoft Office applications
  • Transfers skills/knowledge to the quality team
  • Work effectively in a dynamic and diverse environment
  • Apply quality systems knowledge to identify, open, manage, and effectively close; non-conformance reports, deviations, and corrective and preventive actions

Skills For Senior Quality System Analyst Resume

  • Perform multiple tasks and ability to effectively manage conflict
  • Work effectively with all levels of the organization, and work with minimal supervision
  • Manage workload effectively
  • Business and computer skills
  • Strong experience in statistical analysis with minitab
  • Strong results orientation are required for effective performance in this role
  • Proficiency in computer skills required in Office and ERP Systems
  • Good English, good PC knowledge (MS Office)

Skills For Quality System Leader Resume

  • Basic computer skills (i.e. Word®, Excel®, Visio®, MS Project®, PowerPoint®) required
  • Support in validation activities and control of validation documents
  • Championing and overseeing the effective rollout of Integrated Management initiative (including new Global Procedures, changes to the system, etc.)
  • Coaching ,Training and facilitating skill
  • Monitoring and measuring the effectiveness of the management system
  • Troubleshooting/problem solving experience is required
  • Working experience influencing others to action who are not direct reports
  • Auditing experience or participating to several audits (ISO9001, ISO27001, CMMI, SOX, etc.)

Skills For Quality System Supervisor Resume

  • Working knowledge of, and effective interpretation and application of, Quality Systems regulations and ISO requirements
  • Working closely with Validation Group, System Owner and Business Owner to achieve and maintain Computerized Systems and Data Integrity compliance
  • Tracking, follow-up and implementation of, including but not limited to, ECOs, validation records
  • BSEE (or related engineering discipline) with 10+ years’ experience in managing complex quality systems/ engineering projects/ regulated environment
  • Good English writing and speaking ability
  • Strong audit background, audit facing and audit facilitating

Skills For Quality Shop Director & Quality System Manager Global Propulsion Systems Resume

  • Approve each training material prior to usage and control the set and recording of approved trainings
  • At least three (3) years experience in Quality system of food processing and/or packaged food manufacturing
  • Experience in writing procedures (i.e. Standard Operating Procedures, test protocols, reports, etc.) is required
  • Experience with manufacturing process (Quality or Engineering)
  • Experience in drafting and formatting procedural documents
  • Direct experience with CAPA/Complaint Handling/Internal Auditing
  • Direct experience with hosting/guiding audits from regulatory authorities
  • Experience in the complaint handling, medical device industry, customer relations, complaint trending, FDA/ISO regulations

Skills For Senior Quality System Manager Resume

  • Project management Professional (PMP) certification or similar certification such as KepnerTregor PM training is strongly recommended
  • Demonstrates working knowledge of department quality assurance systems and approaches
  • Locally manages (QMS) improvement projects while maintaining compliance and effectiveness of the QMS
  • Initiate, follow up on and monitor CAPA activities in regards to aging, effectiveness and closure
  • Four (4) years of quality experience in an IVD industry or in a cGMP, ISO regulated Medical Device manufacturing environment

List of Typical Responsibilities For a Quality System Resume


Responsibilities For Quality System Specialist Resume

  • Assist the Quality Manager in coordinating the development and implementation of activities related to the Division’s ISO/TS 16949 Quality System Standard
  • Ensure that the company’s safety rules, all employees including contractors, sub-contractors and other outside parties follow plant standards and environmental guidelines
  • Facilitate and promote a work environment based on fairness and a concern for people, in accordance with the principles of the Magna Employee Charter and the Division’s Employee Handbook
  • Excellent communication, analytical and leadership/people development skills and experience
  • Self-driven personality with high analytical and conceptual thinking as well as excellent interpersonal skills
  • Excellent computer and internet search skills
  • Excellent oral and written communication skills along with the ability to prepare and present information to groups
  • Highly goal-oriented and problem solving, negotiation, and communication skills, with the ability to perform in a complex, global environment

Responsibilities For Quality System Manager Resume

  • Able to clearly provide daily work instructions and delegate effectively
  • Effectively manage direct reports and coordinate efforts of other employees who report to other managers
  • Effectively present information and respond to questions from top management and customers
  • Effectively present information to top management, public groups
  • Maintaining efficient and effective the Quality System
  • Communicating with Internal Auditor/Resources, Safety, Warehouse and other corporate services teams within office to build strong linkages
  • Have experience from working in an international environment, and have interest in understanding and operating within a multi-cultural geographical spread
  • Experience developing SOPs, training & certification systems
  • Experience in taking part in Audits

Responsibilities For Quality System Coordinator Resume

  • Demonstrated aptitude for identifying creative solutions to complex customer issues’ ability to “think outside the box”
  • Good understanding of operations processes
  • Large food production enterprises more than 5 years working experience
  • Experience working with an Integrated Management System (such as ISO 9001)
  • Experience in nonconforming material and CAPA methodologies/systems
  • Previous experience managing a CAPA process is highly desirable
  • Experience in providing leadership of internal auditors team and interaction with external auditors

Responsibilities For Senior Quality System Specialist Resume

  • Experience in understanding customer requirements, external customers interaction if needed
  • Experience in directing the activities of implementation of documented procedures
  • Experience developing Calibrations systems
  • Experience with compliance wire or other training systems is an asset
  • Demonstrated working knowledge of Microsoft Office
  • Manage competing priorities in a fast paced environment, show initiative and be flexible
  • Experience within an Aerospace or Defense or high technology manufacturing organization

Responsibilities For Quality System Analyst Resume

  • A good understanding of Quality Management
  • Demonstrates considerable knowledge of, and success with performing on, compliance-related projects
  • Leadership experience in leading team and/or projects
  • Experience and working knowledge of ISO9001:2015
  • Experience working in Quality Assurance, preferably in Medical Devices

Responsibilities For Senior Quality System Analyst Resume

  • Strong ability to multi-task and to meet business deadlines
  • Play a leading role in the effective implementation of EU MDR
  • In depth experience in leading sites/organizations through FDA, Notified Body and other International Reg Agency Audits
  • Experience in working collaboratively with regulatory partners is essential
  • Review of complaint prior to closure for accuracy and appropriateness of the letter content as well as follow up acknowledgement notice, if required
  • Experience with Quality Systems based on 21 CFR 820 and ISO 13485 Quality System Requirements
  • Knowledge on Quality System TS16949. Experience like internal auditor
  • Attentive to detail; good documentation practices

Responsibilities For Quality System Leader Resume

  • Operate independently with appreciable latitude for actions or decisions on day-to-day activities; seek guidance on novel or controversial issues
  • Strong familiarity with MS Office, Outlook, PowerPoint
  • Self-motivation is essential as is the ability to prioritise
  • Experience in medical device, biologics and/or pharmaceutical field
  • Demonstrated knowledge of domestic and international regulations

Responsibilities For Quality System Supervisor Resume

  • Experience in medical device, biologics and/or pharmaceutical field
  • Assist managers with good documentation controls, project implementations, process review, GCAPA and process improvements
  • Hands-on experience on quality assurance in agile development, especially Scaled Agile Framework (SAFe)
  • Relevant technical, Operations, or Quality Assurance/ Management experience
  • Develops basic quality systems skill sets
  • Collecting, applying and updating all the Company Rules and external rules related to the Quality System

Responsibilities For Quality Shop Director & Quality System Manager Global Propulsion Systems Resume

  • Coordinating of Internal Audit program (Audits for Global Procedures) as set out in the National and Regional audit program using the tools provided
  • Drafting the Quality System Documentation (manual for KPI, Group Procedures, coordination for drafting procedures/job instructions)
  • Training in Quality Systems including relevant regulations and standards
  • Managing change requests to the quality management system
  • Maintaining KPIs and report status to the management representative/DPS management team
  • Working knowledge of FDA GMP regulations and quality system regulations/requirements
  • Working knowledge of Quality System regulatory requirements
  • Drafting and coordination of quality review
  • Working knowledge of Quality Systems Regulatory requirements and application to Company /Unit requirements

Responsibilities For Senior Quality System Manager Resume

  • Understanding of general business principles and structures
  • Having knowledge of distribution, supply chain and logistics
  • Establishing management system for the life cycle of the computerized system and GMP Data
  • Handling stressful situations
  • Working knowledge and application of ISO 13485 and 21 CFR 820
  • Entering of the complaint into the complaint handling system
  • Travelling is not required

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