Sr Mgr, QA/Quality Engineer, Device & Combination Products

Company Overview Our Mission : At Esperion , we are working tirelessly to deliver innovative medicines that help patients reach their goals today, tomorrow, and into the future. Esperion Quality Philosophy: Quality is in all we do because all we do is for our patients. Esperion ’s passion for quality is an integral part of our company culture and is embedded in every aspect of the organization. We are committed to applying the highest quality standards to develop and deliver safe, effective pharmaceutical products that significantly improve the quality of life for the patients and clinical trial participants we serve. Esperion is a fully remote‑based company with a corporate headquarters located in Ann Arbor, MI. The 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 paid time off and holidays. Position Title: Senior Manager, Quality Assurance / Quality Engineer – Device and Combination Products This 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 – US Essential 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,