Associate Director, Quality Assurance

Position Overview

Reporting to the Senior Director of Device Quality and Regulatory (DQ&R), the Associate Director Quality Engineering & Quality Assurance is responsible for independent compliance support of Medical Devices including the device constituent part of Combination Products. Activities include developing, documenting, and maintaining technical business solutions, reviewing and approving medical device/combination product documentation to support regulatory filings and audits of data, policies, procedures, and systems to ensure compliance with Medical Device (21

CFR 820s) and Combination Product current Good Manufacturing ruling (21

CFR part
4), Device Risk Management (ISO 14971) and other worldwide regulations and company requirements.

• 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 Manufacturing and Research and Development divisions 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 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 testing meets 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.
• Lead and manage development of Design and Development File deliverables for medical devices.

• 7 years of relevant work experience.
• Extensive knowledge of applicable medical device regulations (21
  
  CFR
  820, 21
  
  CFR Part 4, EU MDR, ISO 13485).
• Experience with Design Controls / CAPA / Purchasing Controls as it relates to 21
  
  CFR
  820.
• 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.
• Must be able 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.

• Remediation experience desired.
• Knowledge of current GMPs for combination products.
• Certified Lean Six Sigma Green Belt or Black Belt or ASQ (American Society for Quality) certifications preferred.
• Strong understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (QDP); and project management principles desirable.
• Lean Six Sigma Principles and tools such as DOEs, root cause analysis and/or problem‑solving methods desired.
• Experience in the use of root cause analysis and applied statistical techniques.

• A Bachelor’s degree in Science, Engineering or associated fields with a minimum of 7 years related experience OR a Master’s degree in Science, Engineering or associated fields and 5 years related experience OR a Ph.D. in Science, Engineering or associated fields and 3 years of related experience.
• US based – NJ/PA or other US location.
• Travel – Yes, < 10% of the time.

The salary range for…