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

Esperion

Senior Manager overseeing Quality Assurance for medical and combination devices at Esperion. Ensures compliance and quality oversight in FDA and EU regulated environments.

Posted 7/28/2026full-timeRemote • Arizona, Missouri • 🇺🇸 United StatesSenior💰 $166,500 - $175,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive expertise in Quality Assurance and Quality Engineering within the medical device and drug-device combination product sectors, ensuring compliance with regulatory standards and effective project management. Proven ability to lead technical initiatives and manage relationships with external partners and stakeholders in a GxP environment.

Highest-signal resume keywords

Quality Assurance ExperienceQuality Engineering ExperienceRegulatory Compliance KnowledgeProject Management SkillsStakeholder Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality ReviewRegulatory SubmissionsCAPA ManagementRisk ManagementValidation ProtocolsBatch Record ReviewDeviation InvestigationChange ControlStability DocumentationDesign History File Management

Soft Skills

Communication SkillsStakeholder InfluencingLeadership Skills

Industry Keywords

21 CFR Parts 210/21121 CFR Part 4ISO 13485ISO 14971GxP EnvironmentCDMO ManagementRegulatory InspectionsDrug-Device Combination ProductsMedical DevicesQuality Records

Tech Stack

Tools & technologies

Assembly

About the role

Key responsibilities & impact

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
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 complaint handling and investigation activities

Requirements

What you’ll need

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

Benefits

Comp & perks

Health insurance
401(k) matching plan
Performance‑based bonus program
Stock‑based compensation
Paid time off and holidays