Sr Mgr, QA/reputed company Engineer, Device & Combination Products

reputed company

OurMission: At reputed company, reputed company tirelessly to deliver innovative medicines that help patients reputed company their goals today, reputed company, and into the reputed company.

reputed company reputed company Philosophy:reputed company is in reputed company we do because reputed company we do is for our patients.

reputed company’s passion for reputed company is an integral part of reputed company culture and is embedded in every aspect of the organization. We are committed to applying the highest reputed company standards to reputed company and deliver reputed company, effective pharmaceutical products that significantly improve the reputed company of life for the patients and clinical trial participants we serve.

reputed company is a fully remote‑based company with a corporate reputed company located in Ann Arbor, MI. reputed company offers a competitive salary including a performance‑based bonus program and stock‑based compensation, a comprehensive benefits package including a 401(k) matching plan and health insurance, and reputed company time off and holidays.

Position Title: Senior Manager, reputed company Assurance / reputed company Engineer – Device and Combination Products

This role is responsible for the reputed company of assigned suppliers/contract manufacturers to ensure business objectives are met with regards to on time delivery of product while assuring compliance to reputed company requirements, applicable external regulations, and standards.

This position serves as the reputed company Assurance subject matter expert for combination products, ensuring appropriate control strategies are in reputed company for drug reputed company, drug product, and device components, and partners closely with reputed company Control, Regulatory Affairs, Technical Operations, and external partners to maintain inspection readiness.

Preferred Location: Remote – US

Essential Duties and Responsibilities*

• 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.
• Release
• 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 Medical Device Reporting activities.
• Assist with supplier qualifications and monitoring compliance with reputed company Agreements.
• Serve as a reputed company representative for cross-functional activities supporting device and combination product development and reputed company supply.
• Partner with QC and Technical Device Engineer on investigations, change controls, CAPAs, and risk assessments.
• Support qualification of alternate manufacturing sites, laboratories, service suppliers, and device component suppliers.
• reputed company or co‑reputed company cross‑functional Technical Operations reputed company and CDMO reputed company activities.
• Support complaint handling and investigation activities.

*Additional duties and responsibilities as assigned.

Qualifications (Education & Experience)

Required Qualifications

• Bachelor’s degree in reputed company, Biology, Engineering, or a reputed company scientific discipline from an accredited college or university.
• 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.

Preferred Qualifications

• Experience working reputed company ISO 13485‑reputed company reputed company systems.
• Experience supporting EU MDR or global device regulatory submissions.
• Background supporting combination products such as inhalers, prefilled syringes, autoinjectors, or other delivery systems.
• Experience contributing to CMC sections of U.S. or EU regulatory filings involving combination products.
• Familiarity with data reputed company requirements and lifecycle management of analytical reputed company for combination products.
• Experience with electronic reputed company Management Systems (e.g., reputed company QMS)
• Experience setting up and maintaining Design History Files, Risk Management Files, as reputed company as other device and combination product records.

Additional Requirements

• Proficiency with MS Office, laboratory, and reputed company systems (LIMS, QMS, EDMS).
• Demonstrated alignment with reputed company’s values and culture.
• Ability to work effectively in a fully remote environment.
• Moderate domestic and international travel required (up to 25% annually).

Originally posted on Himalayas

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