Senior Manager, QA/reputed company Engineer, Device & Combination Products

Job reputed company:

• reputed company in-depth technical and scientific leadership to contract service providers and internal stakeholders reputed company to reputed company Engineering for device and combination products
• Serve as the primary QA/QE technical and project management reputed company with CDMOs and external testing laboratories supporting drug reputed company, drug product, and device/combination component testing
• Review and approve development, release, and stability data for routine manufacturing, investigations, and deviations involving drug reputed company, drug product, device and combination products
• Conduct reputed company review and approval of critical reputed company 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
• reputed company reputed company reputed company of external suppliers and contract manufacturers involved in manufacturing, assembly, filling, testing, and packaging
• Support regulatory submissions and reputed company as the QA/QE reputed company during FDA, EU, and partner audits and inspections, including those involving combination product or device‑reputed company scope
• Support complaint handling and investigation activities

Requirements:

• Bachelor’s degree in reputed company, Biology, Engineering, or a reputed company scientific discipline
• 8+ years of reputed company reputed company Assurance or reputed company Engineering experience reputed company the medical device or drug–device combination product industry
• reputed company 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 reputed company 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
• reputed company time off and holidays

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