Quality Systems Manager Resume Sample
Eleanore Jerde
9020 Archibald Ferry,
Philadelphia,
PA
+1 (555) 192 2212
Work Experience
Quality Systems Manager
08/2017
-
PRESENT
Dallas, TX
- 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 SOP’s, and associated forms and records
- Manage the internal quality audit program to ensure the company is compliant to ISO standards, corporate SOP’s, process specs and best practices in order to achieve sustainable World Class performance
- Problem solving
- Collaborate with teams and leadership from all service delivery
- Process / Product Improvement
- Maintain and improve current quality system elements to ensure compliance of global medical device regulations pertaining to Quality Systems
Senior Quality Systems Manager
06/2011
-
07/2017
Boston, MA
- Act as consultant in determining efficient and effective methods for meeting regulations
- Prepare, communicate, and evaluate team goals and objectives for continual improvement of the efficiency and effectiveness of the quality system along with providing individuals with professional growth
- Ensure maintenance and implementation of requirements for quality processes, including operational oversight and continuous improvement for proactive quality management. Oversee quality system processes such as CAPA, software validation, distribution controls, etc
- Establish strategic direction for the Corrective and Preventive Action program; including processing, monitoring, reporting and resolving CAPA improvements
- Respond to customer inquiries and submission support
- Facilitate the Quality System Training programs
- Manage, administrate, implement quality system software
- Participates in project performance team meetings on behalf of the job unit in order to provide ideas, methods, or processes for unit/company performance improvement
Plant Quality Systems Manager
06/2006
-
02/2011
Chicago, IL
- Responsible to management of data and presentation of data to management in accordance with Management responsibility procedure
- Travel up to 10% of the time required with the potential for additional travel, as needed
- The Fresenius Knoxville Mfg. Plant is a smoke free campus and maintains a smoke free environment in accordance with state law and company policy
- Vision, purpose – Ability to support and deploy a compelling vision
- Strategic agility - Strong evidence of innovation, strategic thinking and problem solving
- Intellectual capability – intellectually sharp with the ability to demonstrate agile and critical thinking
- Quality expertise – understanding of fundamentals of Quality their application, implementation and evolution toward a mature organization
- Performance Management - Managing and measuring work. Ability to achieve business results through effective goal and priority setting and resource deployment, effective project management and decision making
- Risk and Opportunities realization - proven skills in assessing risks and opportunities with the ability to structure a plan to mitigate or realize each respectively
Education
St. Lawrence University
2001 - 2005
Bachelor's Degree in Engineering
Professional Skills
- Excellent high level oral & written communications skills enabling incumbent to act as a facilitator and/or educator with strong leadership skills
- Proven managerial/leadership skills such as work planning, delegating & evaluating
- Strong leadership and shaping skills (Influencing others and driving changes)
- Excellent written and oral communication skills, including the ability to facilitate groups or teams to deliver desired results
- Strong leadership and communication skills with interaction across the business with the central Quality functions
- Advanced prioritization and multi-tasking skills
- Strong conflict resolution skills with ability to work under pressure
How to write Quality Systems Manager Resume
Quality Systems Manager role is responsible for leadership, interpersonal, computer, advanced, organization, analytical, microsoft, word, business, database.
To write great resume for quality systems manager job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Quality Systems Manager Resume
The section contact information is important in your quality systems manager 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 Systems Manager Resume
The section work experience is an essential part of your quality systems manager 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 systems manager 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 systems manager position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Quality Systems Manager resume experience can include:
- Computer skills, demonstrated proficiency in Microsoft Excel and Word at an intermediate level, database management, math skills
- Very high level of interpersonal skills to work effectively with others within a Global team organization
- Strong leadership skills in managing change as well as managing the activities of technically based employees
- Excellent verbal and written communication skills, including presenting to groups and one-on-one
- Handles tasks with competing priorities effectively
- Demonstrated skills performing root cause analysis
Education on a Quality Systems Manager Resume
Make sure to make education a priority on your quality systems manager resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your quality systems manager 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 Systems Manager Resume
When listing skills on your quality systems manager 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 systems manager skills:
- Good interpersonal skills, mentoring, coaching and strong problem solving skills required
- Good interpersonal skills, mentoring, coaching, strong problem solving skills required
- Excellent written and verbal skills, strong analytical skills
- Excellent interpersonal and communication skills, including technical writing skills
- Excellent interpersonal skills with an ability to communicate technical information effectively
- Demonstrated analytical and data base decision making skills, statistical sampling and analysis and proficiency with Minitab statistical software. CQA/CQE
List of Typical Experience For a Quality Systems Manager Resume
1
Experience For Senior Quality Systems Manager Resume
- Strong interpersonal skills required in areas of verbal/written communications, customer focus, professionalism, coaching, and team building
- Very strong people management and leadership skills with ability to develop others
- Excellent people management and communication skills are essential
- Excellent English language communication skills, both written and verbal
- Demonstrated experience and knowledge of motivating, training, developing and managing people
- Strong listening, assessment, questioning, analytical and problem-solving skill
- Experience working independently, multiple and changing priorities recognizing problems
- Quality validation of sub-contracting Purchase Orders prior to manufacture/packaging
2
Experience For Senior Corporate Quality Systems Manager Resume
- Above average computing skills and sound understanding of global medical device regulations
- Systemic problem solving skills, PPS, 8D, etc
- Upgrade the current Corrective/Preventive action system to a CAPA program with strong RCA controls, timely responsiveness, and good system documentation
- Proficientcomputer skills and abilities with Microsoft Office products (Outlook, Excel,PowerPoint, etc)
- Understanding and practical experience in Design Control requirements, Risk Assessment as applied to Medical Devices (FMEA, FTA, Hazard Analysis, etc.)
- Ensuring effective cooperation with both, internal and external stakeholders
- Effective recruitment and talent management including individual development planning and supporting career development of direct reports
3
Experience For Plant Quality Systems Manager Resume
- Project management experience, including scoping, planning, execution, and resource management
- Experience developing, coaching and motivating employees in a team-based environment
- Engage and develop others - fostering teamwork and building strong relationships, ability to understand others, lead teams and develop people
- Skilled leading cross‐functional teams or working individual
- Collaborates with manufacturing on product and manufacturing changes and ensures verification/validation activities are appropriately executed
4
Experience For N Quality Systems Manager Resume
- Strong working knowledge of Quality System regulations and industry trends including ISO CFR regulations is required
- Seven or more years of experience in managing quality operations in a food-manufacturing environment required
- Knowledge and experience of working with a Quality Management System within Medical Device manufacturing
- Customer focus – demonstrates and unwavering awareness of customers and their needs
- Relevant work experience in food-manufacturing environment, at least 5 of which is in Quality management
- Ensure proper functioning of corrective and preventive action system and effectiveness of changes implemented
- Demonstrated working knowledge of quality systems requirements and process ownership
- Knowledge and experience working with HACCP Programs, GFSI (SQF or BRC)
- Five (5+) or more years of pharmaceutical manufacturing experience
5
Experience For Corporate Quality Systems Manager Resume
- Strong knowledge of manufacturing processes and relevant statistical techniques (Six Sigma, Statistical Process Control)
- Quality auditing experience in a GMP pharmaceutical environment
- Consolidate various locations and divisions into a single electronic QMS solution
- Excellent communication - verbal & written
- Quality Systems Audit experience
- Organised and methodical, with excellent attention to detail
- Manage, drive and implement changes required in the business systems to improve the effectiveness of QMS processes and procedures
- Develop and mentor a strong quality team that supports a world class manufacturing system
6
Experience For Corp Quality Systems Manager Resume
- Reporting gap closure action plan updates for Quality Council and escalating significant risks associated with QMS implementation and adherence
- Working familiarity of automotive OEM quality systems, including TS-16949/IATF requirements
- Engineering and manufacturing departments
- Implementing and maintaining relevant accreditations
- Liaising with external parties (i.e. vendors, clients) in contractual matters, related to quality process services, within given authority levels
- Leading a team of quality process professionals
7
Experience For Program Quality Systems Manager Resume
- Understanding of Health Canada Recall requirements and ability to work with international partners on C&R programs
- Conducting and/or participating in Root Cause Analysis investigations regarding Food Safety and Quality issues
- Working knowledge of cGMP’s and regulations
- Understanding of the value of a PV Quality Management System
- Understanding and wide application of technical principle, quality tools and best practices in the field (example COS, FTQ)
- Working knowledge of quality assurance and systems as related to medical device design, production and distribution across multiple sites or entities
- Responsible for attracting top talent, developing, training, mentoring, and motivating team members
- Manages site audit plan, including issuing audit reports and communication to managers; tracks audit commitments and manages monthly reporting
8
Experience For Senior Global Quality Systems Manager Resume
- Responsible for maintain the integrity of the Training system, including the oversite and development of training curriculums and programs
- Initiate training and team development on SAP and other management systems / labeling/ bartender, Marco, packaging verification system etc..,
- Leads the plant in determining the annual Quality Program training needs and assists in the scheduling and implementation of these programs plant wide
- Assists in determining disposition of hold materials using opportunities to reprocess out of specification, obsolete or slow moving materials
- Responsible for educating and training key individuals regarding the Corporate Quality System programs
- Works closely with other functions on site, including manufacturing and engineering, to communicate and implement relevant Quality Systems
- Develop and maintain related Food Safety standards in AAK together with Business Area’s, European Supply Chain, Purchasing and Sourcing & Trading
9
Experience For Quality Systems Manager Resume
- Assists in determining disposition of hold materials using opportunities to reprocess out of specification, obsolete or slow-moving materials
- Establish and maintain successful cross-functional relations with R&D, Engineering, Manufacturing, Marketing, Quality, and Regulatory Affairs departments
- Responsible for recruiting, training, and coaching all direct reports
- Leads efforts to overhaul current training system, transforming to competency-based learning model
- Oversee thermal processes with authority for procedures and protocols associated with solution heat treating, quenching, aging, and associated operations
- Facilitate training of functional areas and develop appropriate training for personnel involved in the execution of Quality System processes
- Promote quality improvement through the use of risk-based thinking, statistical & LSS (Lean Six Sigma) problem-solving techniques
- Deliver comprehensive and business savvy Quality programs and metrics to Pepperidge Farm manufacturing locations including Comanufactures
10
Experience For Senior Quality Systems Manager Resume
- Technically proficient in understanding engineering and construction quality management and controls
- Coach and mentor subordinates in the areas of training, disciplinary action, problem solving, and professional growth
- Change Control: review and approval for process, product and facility change proposals, including trending and assessment of impact of changes over time
- Ensure assessment learning’s are addressed and all outstanding issues
- Lead the adaptation and improvement of the site QMS in the perspective of a major on-going project and the upcoming MDR
- Upward mobility in a thriving organization in our fastest growing business unit
List of Typical Skills For a Quality Systems Manager Resume
1
Skills For Senior Quality Systems Manager Resume
- Demonstrated experience in management of pharmaceutical quality systems including quality control and quality assurance experience
- Good verbal, written, communication and presentation skills
- Proven ability to work effectively within a team environment while satisfying individual responsibilities and objectives
- Proven leadership skills with the ability to build a successful team and drive results
- Excellent IT skills - Word/Excel
- Experience reacting to multiple and changing priorities and successfully achieving results within a compressed time frame
2
Skills For Senior Corporate Quality Systems Manager Resume
- Expert in problem solving and analytical skills using 8D methodology
- Team work & networking skills
- Leadership skills, team building and development
- Facilitate and/or support validation training, change control, periodic review of validated systems, equipment, and support change management
- Manage and execute on multiple, critical projects simultaneously. Strong ethics to escalate issues in the face of competing corporate priorities
- Prior laboratory experience with chemical analytical analysis, microbiological testing, and/or laboratory supervision
- Good prioritization capability and comfortable adapting to meet production needs
- Fluency in English Demonstrated effective interpersonal,
3
Skills For Plant Quality Systems Manager Resume
- Computer & office based work skills necessary but a hands on approach is essential in the production facility
- Advanced analytical and procedural development skills
- Experience in QA or other relevant experience
- Highly developed communication skills (oral, written, and presentation)
- Quality Planning – ability to effectively implement Customer and regulatory requirements
- Proven Quality experience operating in AS9100, AS9110, TickIT, EASA Part-21 & Part-145 environments
- Function independently, influence a wide range of stakeholders and problem solve effectively
- Ensure system access is controlled and effectively monitored
4
Skills For N Quality Systems Manager Resume
- Experience with application of FDA and ISO quality standards in a government regulated healthcare industry. Experience with FDA (or Notified Body) inspections
- Create and effectively communicate regulations/standards
- Develops programs that ensure all employees possess the knowledge, skills, and abilities to execute their job responsibilities
- Possessing a good working knowledge of the Microsoft (MS) Windows OS as well as MS Office Suite applications such Word, Excel, PowerPoint, Outlook, etc
- Possessing a valid FAA AMT license with an Airframe and/or Powerplant rating
- Possessing a valid driver’s license
- Experience recognizing problems, analyzing them, offering solutions and using logical thought processes when making decisions
- Practical experience with liquid filling, aseptic filling, environmental monitoring and/or other microbiological control for manufacturing/packaging processes
- Manages the plant quality training program including the facilitation of training creation, delivery, recording completion rates, and effectiveness measurement
5
Skills For Corporate Quality Systems Manager Resume
- Experience leading direct reports, developing, coaching and motivating employees
- Utilize problem solving experiences and expertise using a variety of problem solving methods
- Experience developing, coaching and motivating employees in a team based environment
- Experience developing processes, writing procedures and training hourly and exempt associates
- Five to seven years Quality Assurance management experience within the food manufacturing or food packaging industries
- Experience managing the Quality System and departmental activities within medical device or pharmaceutical manufacturing companies
6
Skills For Corp Quality Systems Manager Resume
- Experience leading teams and/or managing direct reports
- Experience reading and interpreting technical documents such as specifications, procedure manuals, and technical data sheets
- Proficiency in setting priorities and executing multiple assignments in a timely and efficient manner
- 5 years' experience in the automotive industry manufacturing and assembly environment
- Experience in manufacturing; specifically sheet metal and machined components and assemblies
- QA experience within a food manufacturing environment – essential
- Operate various related ground handling equipment utilized to service aircraft
- Demonstrate prudent judgment when deciding which records/issues require escalation to upper management
7
Skills For Program Quality Systems Manager Resume
- Experience with quality systems within a manufacturing environment
- Certified Lead Auditor training or relevant experience
- Experience with audits (FDA, Notified Body and Certification Testing Laboratories)
- Knowledge and experience working with HACCP Programs and related required documentation
- Experience with Class II or III medical device/pharmaceutical manufacturer or in related medical manufacturing industries
- Develops and distributes metrics to measure compliance and effectiveness of training program
8
Skills For Senior Global Quality Systems Manager Resume
- Knowledge of and experience with all FDA regulatory requirements concerning class I, II, and III devices
- Leadership experience in the planning, execution and closure of field corrective actions in the medical device industry
- Strong knowledge of medical device regulations and quality standards, including 21 CFR Part 820, ISO 13485, and EU MDR
- Experience in communicating directly with global regulatory bodies
- Experience in leading technical projects
- Experience and participation in medical device industry collaborations, such as standards working groups, industry consortiums or associations
- Develop the Management Systems strategy and the management arrangements for key milestone, demonstrating solid progress against plan
9
Skills For Quality Systems Manager Resume
- Experience in plant & quality environment including various positions out of the quality (nice to have program and/or R&D)
- Maintain and assemble information relating to prior commitments, required documentation, and Regulatory intelligence and site/facility issues
- 10 years' experience in automotive quality systems
- 5 years' experience in ISO 9001 and TS 16949
- Excellent communicator with sharp customer focus
- Operates with integrity and is respectful
- Strong motivator and leader with a willingness to share best practice and work on the common look and feel principals
- Focus on customers with a strong sense of responsibility towards existing and future potential customers
10
Skills For Senior Quality Systems Manager Resume
- Experience with weld specifications
- Experience with Non-Destructive Inspection
- Experience with heat treatment
- 5+years quality assurance experience in a medical device environment
- Quality experience with at least 5 years as a Quality Manager
- Industry experience in polymers, resins or plastics and six sigma expertise
- Working experience) in a regulated medical device and/or pharmaceutical industry
List of Typical Responsibilities For a Quality Systems Manager Resume
1
Responsibilities For Senior Quality Systems Manager Resume
- Ensure the Construction Site Quality Manager effectively manages all on-site QC inspection and testing activities
- Project management skills of projects spanning across different functional and international environments
- Work experience including 3+ or more years of relevant quality system experience in a medical device manufacturer
- Manages audit follow-up, including participating in root cause analysis (where required), reviewing and agreeing CAPA plan and monitoring CAPA effectiveness
- Maintains Good Manufacturing Practices (GMPs) and Standard Operating Procedures (SOPs) related to the quality of our packaging lines
- Manage and maintain the CAPA process, supporting CAPA owners with effective planning and execution of CAPA projects
- Experience with training or mentoring others is required
- Experience with Automotive Quality Management System auditing and managing audit programs, specifically IATF 16949 AND ISO13485
2
Responsibilities For Senior Corporate Quality Systems Manager Resume
- Experience in Auditing and notified body inspections required
- Experience with root cause investigation, change management, risk management and technical writing required
- Significant experience in a high-volume manufacturing environment, preferably automotive
- Experience in leading subordinate staff to high levels of compliance
- Experience of compliance in a PV setting
- Experience working in both an FDA and European regulatory environment is required
3
Responsibilities For Plant Quality Systems Manager Resume
- Experience managing CAPA process is required
- Thermal processing experience
- Experience working well with all levels of employees, as well as internal and external customers in both individual and team-based situations
- Experience with lean manufacturing and six sigma philosophy and tools
- People management experience including the ability to motivate and mentor
- Experience with Quality Systems Management and Quality Control - Includes both design and construction
- Previous Quality System experience of 5 years required
- Coordinate and prioritize project deliverables (as applicable) of the Quality department
- Investigate deviations against the quality system and develop effective corrective action plans
4
Responsibilities For N Quality Systems Manager Resume
- Quality systems demonstrated knowledge in areas such as deviation, CAPA and EV systems management
- Generation of formal audit plan/schedule, confirmation of completion and follow up on the effectiveness of implemented corrective actions
- Oversees the documentation system, change control, and ensures Good Documentation Practices are followed
- Strong knowledge of change control/deviation practices/strategies
- Quality systems demonstrated knowledge in areas such as change control, deviation, CAPA and EV systems management
- Interacts with McCormick corporate and customers at any and all levels required to establish and maintain effective business relationships
- Facilitating and ensuring thorough Root Cause Analyses are conducted for complaints and CAPAs are sustainable and prevent future occurrences
- Building capability of L1 Auditors
5
Responsibilities For Corporate Quality Systems Manager Resume
- Working knowledge of ISO9001, IATF 16949, VDA
- Working knowledge for Automotive industry OEM specific requirements
- Manufacturing & Quality background
- Contacting internal and external experts to help resolve issues and benchmark best practices
- Works closely with Quality, Manufacturing, R&D/Engineering functions to ensure QS programs are adhering to current requirements
- Assists in writing/revising and maintaining task, department, and general SOPs
- Responsible for employee training system and tracking to meet operational, regulatory, and accreditation requirements
- Oversees the plant sanitation and GMP compliance through managing the pest control and environmental control programs and auditing the sanitation procedures
6
Responsibilities For Corp Quality Systems Manager Resume
- Drive Level II PD for the PCKAM businesses, including the development of metrics, trending, and CM’s related to TTI’s and KPI’s
- Support purchasing on defining quality and food safety requirements for raw materials and suppliers
- Perform GMP Training for relevant staff and attend required training programmes
- Develop quality strategies for the global manufacturing sites supporting the organizations strategic goals
- Leads on-site QPR and QSMR, including coordination, preparation, execution, and tracking of activities,
- Collaborate and prepare recommendations with Technology Managers, Manufacturing & Converting leaders, and business leads to solve problems for customers
7
Responsibilities For Program Quality Systems Manager Resume
- Assist the project management team in planning and implementing Jacobs quality requirements on the project
- Assist the project management team in assuring project team is adhering to Jacobs work processes and work instructions
- Monitors product development, manufacturing, and post-market data to ensure appropriate action is taken with respect to ongoing risk management
- Sets strategic direction for the function and the use of its personnel, including departmental goals and budgeting
- High level computer literacy; including MS Office, SharePoint, Flowcharting software, Acrobat, etc
- Working knowledge of applicable external regulatory standards, including FDA 820, ISO 13485 and international standards
- Visual capacity including depth perception, color vision, and peripheral vision enabling operation of office machinery
- Develop, establish and deploy process control and capability to ensure and maintain product quality while minimizing cost and maximizing productive capacity
- Provide quality training and maintain non-safety related training records for employees
8
Responsibilities For Senior Global Quality Systems Manager Resume
- Provide training coaching and support to QMS personnel
- Creation and reporting of a dashboard for Global Quality Standards to the Global Quality Council
- Creation, drafting, and revision of Global Quality Standards for Shire
- Develop comprehensive training programs for Quality initiatives and foundational programs
- Creation of employee development plans, and oversight of functional area to assure adequate staffing
- Provide support for activities using the electronic document repository system
- Review of SOPs, Work Practices and training materials as required
- Implement and monitor sample (testing) plans to ensure product quality
9
Responsibilities For Quality Systems Manager Resume
- Complaints: review and approval of complaints; coordination of complaints programme and trending of complaints
- Acts as liaison with appropriate local, national and international regulatory authorities, including FDA and AATB
- Ensures compliance with all applicable federal, state, and local accreditation requirements, company policies and standard operating procedures
- Oversees the review and approval of product and manufacturing quality controls and changes for adherence to quality system requirements
- Ensure individual change records are developed and documented in accordance with Kite’s governing procedure
- Develop, implement and deliver training content for change control, deviation, CAPA and EV processes and procedures
- Responsible for policy/procedure reviews and facilitating updates for the change control, deviation, CAPA and EV systems
- Leads the development, maintenance, and auditing of the plant Quality systems and specific customer driven programs
- Manage and Develop the Quality Management System – Serving as the local Management Representative
10
Responsibilities For Senior Quality Systems Manager Resume
- Hosts quarterly Management Review meetings, including comprehensive data analysis
- Through the tracking, statistical analysis and evaluation of quality data , assimilate trends and provide global improvement recommendations
- Manages and maintains the Post Market Surveillance function and regulatory reporting related activities
- Creates, implements and provides training on Quality procedures
- Ensures that customer requirements are met by managing the internal certification process
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