Associate Director – Quality Assurance

This is a fully remote position, open to applicants in New Jersey, +1 more state.

📋 Description

• Reporting to the Senior Director of Device Quality and Regulatory (DQ&R), the Associate Director of Quality Engineering & Quality Assurance will provide independent compliance support for Medical Devices, including the device constituent part of Combination Products.

• Collaborate with cross-functional teams, engaging with employees at all levels.

• Develop, document, and sustain technical business solutions by reviewing and approving documentation for medical devices and combination products to aid in regulatory filings and audits of data, policies, procedures, and systems, ensuring adherence to Medical Device regulations (21CFR 820s) and Combination Product current Good Manufacturing Practices (21CFR part 4), Device Risk Management (ISO 14971), along with other global regulations and company standards.

• Offer Device quality engineering and quality assurance support and guidance to guarantee effective quality oversight of upcoming medical devices and medical device combination products.

⛳️ Requirements

• A minimum of 7 years of relevant work experience.

• In-depth knowledge of applicable medical device regulations (21CFR820, 21CFR Part 4, EU MDR, ISO 13485).

• Experience with Design Controls, CAPA, and Purchasing Controls as they pertain to 21CFR820.

• Background in Risk Management (ISO 14971/24971, ICH Q9).

• Strong communication skills and familiarity with device development and commercialization, product approval, and/or regulatory inspection experience involving medical devices.

• A Bachelor’s degree in Science, Engineering, or related fields with at least 7 years of relevant experience, OR a Master’s degree in Science, Engineering, or related fields with 5 years of relevant experience, OR a Ph.D. in Science, Engineering, or related fields with 3 years of relevant experience.

🏝️ Benefits

• Medical, dental, vision healthcare, and other insurance benefits for employees and their families.

• Retirement benefits, including a 401(k) plan.

• Paid holidays.

• Vacation time.

• Compassionate and sick days.