Industry: Pharmaceutical

Purpose:
Responsible for representing Quality Assurance on cross-functional teams, ensuring products are properly transferred from development to manufacturing, and maintained on the market in compliance with internal policies and external regulations. Products include medical devices and combination products such as infusion pumps, pre-filled syringes, autoinjectors, eyecare devices, and aesthetic products.

Key Responsibilities:

• Lead quality and compliance activities for design transfer and on-market change management.
• Serve as primary QA lead for product launches, including internal and external transfers.
• Mentor and guide cross-functional teams on design transfer processes and quality best practices.
• Manage on-market design changes, including impact assessment, action plan execution, and monitoring.
• Ensure design control and change control documentation compliance.
• Identify gaps in quality processes and lead improvement initiatives.
• Support regulatory inspections, audits, and represent QA as a subject matter expert.
• Collaborate with suppliers, contract manufacturers, and internal stakeholders to maintain quality standards.
• Conduct investigations and participate in review boards for CAPAs, NCRs, and change plans.

Qualifications:

• Bachelor’s degree in Science, Engineering, or related technical field; advanced degree preferred.
• 8+ years in the medical device industry, with at least 5 years in Quality Assurance.
• Knowledge of ISO 13485, ISO 14971, 21 CFR 4 & 820, EU MDD & MDR regulations.
• Experience with medical devices and/or combination products (e.g., infusion pumps, PFS, autoinjectors) preferred.
• Strong problem-solving, project management, and interpersonal skills.
• Proven ability to lead cross-functional teams and influence outcomes without direct authority.
• Adaptable, collaborative, and able to thrive in a fast-paced environment.

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)