Associate Director, Quality Assurance

About the role

This position represents the DQ&R Quality function on commercial and product/core development teams, supporting quality issues related to medical devices or the device constituent of a combination product.

Responsibilities

• Actively represent DQ&R Quality function on commercial and product/core development teams supporting quality issues related to medical devices or the device constituent of a combination product.
• Review and approve Design Control and Device Risk Management documentation for regulatory filings, clinical supply, development, design transfer qualification and post marketing surveillance.
• Evaluate deficiencies and assess impact on compliance status.
• Contribute to developing/revising policy and procedures for DQ&R Quality and/or supported areas.
• Remain informed of industry trends as described in worldwide regulations and industry standards.
• Provide guidance to our Manufacturing Division and our Research and Development Division device functions and other personnel to ensure end-to-end Design Control principles are implemented effectively.
• Participate in design reviews, CAPA reviews, and ad-hoc technical reviews of combination products.
• Participate in all stages of combo product development including but not limited to oversight of purchasing controls and supplier quality.
• Work with external partners to develop products.
• Review and approve verification/validation test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.
• Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
• Facilitate translation of customer needs into critical to quality and design input/output requirements, including but not limited to chemical, physical, or performance specifications.
• Lead and manage development of Design and Development File deliverables for medical devices.

Requirements

• 7 years of relevant work experience.
• Extensive knowledge of applicable medical device regulations (21CFR820, 21CFR Part 4, EU MDR, ISO 14971) and Risk Management experience (ISO 14971/24971, ICH Q9).
• Effective communication skills and working knowledge of device development and commercialization, product approval, and/or regulatory inspection experience with medical devices.
• Ability to work independently within a cross functional framework and will involve detailed technical writing and review.
• A high degree of creative thinking, resourcefulness, and networking will be required to coordinate projects or solve problems.
• Ability to work in a matrix organization and effective written and oral communicator.

Qualifications

• A Bachelor’s degree in (Science or Engineering or associated fields) with a minimum of 7 years related experience OR a Master’s degree (Science or Engineering or associated fields) and 5 years related experience or a Ph.D. (Science or Engineering or associated fields) and 3 years of related experience.