Job Description:
• Provide in-depth technical and scientific leadership to contract service providers and internal stakeholders related to Quality Engineering for device and combination products
• Serve as the primary QA/QE technical and project management liaison with CDMOs and external testing laboratories supporting drug substance, drug product, and device/combination component testing
• Review and approve development, release, and stability data for routine manufacturing, investigations, and deviations involving drug substance, drug product, device and combination products
• Conduct quality review and approval of critical quality records and documents, including batch records, deviations, investigations, CAPAs, change controls, complaints, risk management, validation protocols and reports, stability documentation, Design History File, and Annual Product Reviews (APR)
• Ensure compliance with applicable combination product regulatory requirements, including 21 CFR Parts 4, 210, 211, 820, ISO 13485 and other relevant regulations
• Provide quality oversight of external suppliers and contract manufacturers involved in manufacturing, assembly, filling, testing, and packaging
• Support regulatory submissions and act as the QA/QE lead during FDA, EU, and partner audits and inspections, including those involving combination product or device‑related scope
• Support complaint handling and investigation activities
Requirements:
• Bachelor’s degree in Chemistry, Biology, Engineering, or a related scientific discipline
• 8+ years of progressive Quality Assurance or Quality Engineering experience within the medical device or drug–device combination product industry
• Direct experience supporting medical devices and/or drug–device combination products in a regulated GxP environment
• Strong working knowledge of: 21 CFR Parts 210/211 (cGMPs), 21 CFR Part 4 (Combination Products), ISO 13485 and ISO 14971, ISTA, Applicable elements of 21 CFR Part 820
• Proven experience managing global external CDMOs and contract testing laboratories
• Experience supporting regulatory inspections and audits, including preparation and response activities
• Strong project management, communication, and stakeholder‑influencing skills in a matrixed environment.
Benefits:
• Health insurance
• 401(k) matching plan
• Performance‑based bonus program
• Stock‑based compensation
• Paid time off and holidays