Position Title: Senior Manager, Quality Assurance / Quality Engineer - Device and Combination ProductsThis role is responsible for the quality of assigned suppliers/contract manufacturers to ensure business objectives are met with regards to on time delivery of product while assuring compliance to Esperion requirements, applicable external regulations, and standards.
This position serves as the Quality Assurance subject matter expert for combination products, ensuring appropriate control strategies are in place for drug substance, drug product, and device components, and partners closely with Quality Control, Regulatory Affairs, Technical Operations, and external partners to maintain inspection readiness.
Preferred Location: Remote - USEssential Duties and Responsibilities*- 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.
- Release
- 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 Medical Device Reporting activities.
- Assist with supplier qualifications and monitoring compliance with Quality Agreements.
- Serve as a Quality representative for cross-functional activities supporting device and combination product development and commercial 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.
- Lead or co-lead cross-functional Technical Operations projects and CDMO oversight activities.
- Support complaint handling and investigation activities.
*Additional duties and responsibilities as assigned.
Qualifications (Education & Experience)Required Qualifications- Bachelor's degree in Chemistry, Biology, Engineering, or a related scientific discipline from an accredited college or university.
- 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.
Preferred Qualifications- Experience working within ISO 13485-aligned quality 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 integrity requirements and lifecycle management of analytical methods for combination products.
- Experience with electronic Quality Management Systems (e.g., Veeva QMS)
- Experience setting up and maintaining Design History Files, Risk Management Files, as well as other device and combination product records.
Additional Requirements- Proficiency with MS Office, laboratory, and quality systems (LIMS, QMS, EDMS).
- Demonstrated alignment with Esperion's values and culture.
- Ability to work effectively in a fully remote environment.
- Moderate domestic and international travel required (up to 25% annually).
