Senior Manager, Quality Assurance / Quality Engineer - Device and Combination Products
$166,500–$193,000 year
RemoteUnited States
Job Summary
Lead Quality Assurance for assigned suppliers and contract manufacturers, ensuring on-time delivery while maintaining compliance with 21 CFR Parts 4, 210, 211, 820, ISO 13485, and other regulations. Serve as the primary technical liaison with CDMOs and external laboratories for drug substance, product, and device component testing, reviewing and approving development, release, stability data, and critical quality records including batch records, deviations, CAPAs, and Design History Files. Provide quality oversight of external manufacturing and support regulatory submissions, acting as the QA lead during FDA, EU, and partner audits. Manage supplier qualifications, monitor Quality Agreements, and lead cross-functional projects for device and combination product development. Requires 8+ years of GxP experience in medical devices or combination products, with moderate international travel up to 25% annually.
Required Qualifications
- 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, and 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
- Ability to work effectively in a fully remote environment
- Moderate domestic and international travel required (up to 25% annually)
Desired Qualifications
- Experience working within ISO 13485-aligned quality systems is a plus
- Experience supporting EU MDR or global device regulatory submissions is a plus
- Background supporting combination products such as inhalers, prefilled syringes, autoinjectors, or other delivery systems is a plus
- Experience contributing to CMC sections of U.S. or EU regulatory filings involving combination products is a plus
- Familiarity with data integrity requirements and lifecycle management of analytical methods for combination products is a plus
- Experience with electronic Quality Management Systems (e.g., Veeva QMS) is a plus
- Experience setting up and maintaining Design History Files, Risk Management Files, and other device and combination product records is a plus
- Proficiency with MS Office, laboratory, and quality systems (LIMS, QMS, EDMS)
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