[Hiring] Associate Director, Quality Assurance @Merck

Role Description

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. This position will interact with cross functional teams working with all levels of employees. Activities will include:

• Developing, documenting, and maintenance of 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 (21CFR 820s) and Combination Product current Good Manufacturing ruling (21CFR part 4).
• Providing Device quality engineering and quality assurance support and leadership to ensure successful quality oversight of prospective medical devices and medical device combination products.

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 in Science or Engineering or associated fields and 5 years related experience OR a Ph.D. in Science or Engineering or associated fields and 3 years of related experience.
• 7 years of relevant work experience.
• Extensive knowledge of applicable medical device regulations (21CFR820, 21CFR Part 4, EU MDR, ISO 13485).
• Experience with Design Controls / CAPA / Purchasing Controls as it related to 21CFR820.
• 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 involving detailed technical writing and review.
• Ability to work in a matrix organization and effective written and oral communicator.

Requirements

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

Benefits

• Comprehensive package of benefits including medical, dental, vision healthcare and other insurance benefits (for employee and family).
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.