Senior Manager, QA/Quality Engineer, Device & Combination Products

This is a fully remote position, open to applicants in Michigan.

📋 Description

• Deliver comprehensive technical and scientific guidance to contract service providers and internal stakeholders concerning Quality Engineering for device and combination products.

• Act as the main QA/QE technical and project management point of contact with CDMOs and external testing laboratories that assist with drug substance, drug product, and device/combination component evaluations.

• Examine and authorize development, release, and stability data for routine manufacturing, investigations, and deviations related to drug substance, drug product, device, and combination products.

• Perform quality reviews and approvals of essential quality records and documents, such as 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 adherence to relevant combination product regulatory requirements, including 21 CFR Parts 4, 210, 211, 820, ISO 13485, and other applicable regulations.

• Provide quality oversight for external suppliers and contract manufacturers engaged in manufacturing, assembly, filling, testing, and packaging.

• Assist with regulatory submissions and serve as the QA/QE lead during FDA, EU, and partner audits and inspections, particularly those involving combination products or device-related scopes.

• Support activities related to complaint handling and investigations.

⛳️ Requirements

• Bachelor’s degree in Chemistry, Biology, Engineering, or a related scientific field.

• Over 8 years of progressive experience in Quality Assurance or Quality Engineering within the medical device or drug–device combination product sector.

• Direct experience in supporting medical devices and/or drug–device combination products within a regulated GxP environment.

• Strong familiarity with: 21 CFR Parts 210/211 (cGMPs), 21 CFR Part 4 (Combination Products), ISO 13485 and ISO 14971, ISTA, and relevant elements of 21 CFR Part 820.

• Demonstrated experience managing global external CDMOs and contract testing laboratories.

• Experience in supporting regulatory inspections and audits, including preparation and response activities.

• Excellent project management, communication, and stakeholder-influencing abilities in a matrixed setting.

🏝️ Benefits

• Health insurance

• 401(k) matching plan

• Performance‑based bonus program

• Stock‑based compensation

• Paid time off and holidays