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Dir, Global Quality Systems

Performance Health | Akron OH 44310 USA | Full Time | Posted: 10/11/2019

Job Descriptiontop

Performance Health is seeking a Director of Global Quality Systems to join our team in Akron, OH. This position is responsible for establishing and maintaining Quality System policies and procedures in compliance with applicable global medical device and drug quality regulations across sites. Additionally, they are responsible for ensuring compliant and effective execution of the Quality System across North American manufacturing sites.

To perform this job successfully, an individual must be able to perform each essential job duties satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Essential Job Duties & Responsibilities
Lead team in establishing & maintaining Performance Health s global Quality System policies and procedures in compliance with ISO 9001, ISO 13485, 21 CFR 201 & 211, 21 CFR 820 and other regulatory/quality standards as applicable.
Ensure compliant and effective execution of the Quality System globally through use of internal audits, timely regulatory intelligence, and monitoring key quality measure/metrics
As Quality System subject matter expert, interact with and provide process leadership & guidance to global leaders and their teams
Assist the VP Regulatory Affairs and Quality Assurance in preparing and conducting periodic corporate level Quality Management Reviews summarizing performance across global sites
Manage/Lead North America site Quality leaders in driving effective, timely, and compliant execution of the Quality System
Assure quality systems at internal and external manufacturing locations meet applicable US and international regulatory requirements through implementing effective audits and corrective actions
Provide oversight/leadership during ISO and FDA site audits/inspections to maintain site registrations and certifications
Identify and drive significant product and process Quality improvements via establishing effective cross functional relationships and use of proven data analysis tools/methodologies such as SPC, 6 Sigma, Lean, DOE, and FMEAs
Provide product and process Verification and Validation leadership/guidance across sites
Drive timely investigation of customer complaints in identifying potential cause(s) and determining if additional investigation and Corrective Action is required via the CAPA process
Participate in the design and launch of new products to ensure expectations for quality, performance, regulatory compliance, and delivery are understood and achievable
Participate in selection and maintenance of suppliers through effective management of supplier audits and timely resolution of supplier defects
Performs other duties as assigned

Job Qualifications
Bachelors of Science degree in Engineering or other related technical field
10 years of experience within a medical device regulated industry (e.g. FDA, ISO)
5 years management/supervisory experience
Demonstrated understanding of data-driven electronic Quality data analysis tools such as Minitab & Excel pivot tables, and problem solving methodologies such as 6 Sigma, and SPC
Strong knowledge and understanding of FDA 21 CFR Part 201, 210, 211, 803, 806, & 820, ISO 14971 and ISO13485 regulatory/quality standards
Ability to travel up to 10% of the time, including overnight travel

Performance Health is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, and any other characteristic protected by law.

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Location Akron, OH, 44310, United States
Categories Medical/Health

Location Maptop

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Job Code 305494

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