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The Manager, Quality Systems is responsible for assigned GMP compliance activities. This includes managing the Quality Systems group, which manages key areas of the business such as Nonconformance, CAPA, Customer Complaint Investigations, and other QA initiatives. This position will lead interactions between Product Development and Manufacturing Engineering and organizes and manages the activities of the Quality Systems group to identify and meet the GMP compliance needs for manufacturing and product development. These activities and interactions include the development, implementation, and distribution of all Quality System Documentation to ensure that the development, manufacture, and distribution of medical products are in compliance with company policies and procedures, US Food and Drug Administration regulations, ISO 13485, the Canadian Medical Device Regulations (CDMR), the Medical Device Directive, and other applicable regulatory agencies.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Primary responsibilities are to:

• Maintain thorough understanding of the following guidelines and regulations: FDA GMPs, ISO9001, ISO 14971, ISO 13485 standards, Integra policies and procedures, and other applicable standards.

• Manage Quality Systems support for Manufacturing, QA/QC, Regulatory and Product Development

• Manage the Nonconformance System for products and processes, including assuring material is properly quarantined and determining appropriate reviewers and approvers.

• Ensure investigations are complete, accurate, and on time.

• Manage the CAPA system, implement process improvements to increase the efficiency and effectiveness of the CAPA investigations.

• Conduct trend analysis of nonconformances, CAPAs, complaints, APR, and other quality indicators.

• Build a strong team of quality system engineers through active hiring, retaining, and motivating individuals

• Participate in external audits such as FDA, Notified Body (BSi), and corporate

• Benchmark regulatory and industry practices. Engage in discussion groups and committees that set or influence policies and guidelines.

• Performs other related duties as necessary.

The requirements listed below are representative of the knowledge, skill and/or ability required for his position.

• Education: BS Engineering or Science Degree

• Experience: 7-10 years quality assurance engineering and reliability supporting manufacturing (product development a plus).

• Excellent written and verbal effective communication skills.

• Working knowledge of GMP and Quality Systems required, and experience in medical device industry is strongly preferred.

• Demonstrated knowledge of FDA GMPs, ISO9001, ISO 14971, ISO 13485 standards, and other applicable standards.

• Must have demonstrated ability to think strategically.

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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