Top 17 Supplier quality engineer Jobs in Chelsea, Mi

Sr Mgr, QA/Quality Engineer, Device & Combination Products
ESPERION THERAPEUTICS INC —Ann Arbor, MI
- $166,500 - $175,000 a year
- Remote
- Laboratory experience
- Microsoft Office
- Travel
- Paid holidays
- Health insurance
Quick Apply
Plant Quality Engineer
Faurecia —Saline, MI
- Engineering
- Mid-level
- Training & development
Supplier Quality Engineer
Katalyst Healthcares & Life Sciences —Dexter, MI
- Contract
- Engineering
- ERP systems
- 8 years
Quick Apply
Quality Engineer II
East Penn Manufacturing - Deka Batteries —Ann Arbor, MI
- Full-time
- Engineering
- Mid-level
- 3 years
- Paid holidays
- Health insurance
12d
Quality Systems Engineer
American Tooling Center —Grass Lake, MI
- $70,504.66 - $80,000.00 a year
- Overtime
- Background check
- Mid-level
- Office
- Health insurance
- Dental insurance
Quick Apply
Sr. Global Supplier Quality Engineer
KLA —Ann Arbor, MI
- $102,200 - $173,700 a year
- Full-time
- 3 years
- Master's degree
- Bachelor's degree
- Employee stock purchase plan
- Paid holidays
Production Quality Engineer
Eaton —Jackson, MI
- $71,000 - $105,000 a year
- Background check
- Microsoft Excel
- Microsoft Outlook
- Retirement plan
12d
Quality Engineer
Milsco LLC —Jackson, MI
- Mid-level
- Bachelor's degree
- Experience equivalent to degree accepted
Quick Apply
Test Engineer
East Penn Manufacturing - Deka Batteries —Ann Arbor, MI
- Full-time
- 1 year
- Electrical Engineering
- Python
- Paid holidays
- Health insurance
Impact Safety Test Engineer
Stellantis —Chelsea, MI
- Holidays
- Bachelor of Science
- 3 years
- Supervising experience
Test Engineer A/Sr
NSK Corporation —Ann Arbor, MI
- Hybrid work
- 6 years
- Analysis skills
- Continuous improvement
- Disability insurance
- Health insurance
Quick Apply
Validation Engineer
BWI Chassis Dynamics (NA) Inc. —Brighton, MI
- Email
- Microsoft Outlook
- Computer literacy
- English
Quick Apply
Supplier Quality - Packaging
Wells Enterprises —United States
- $93,959.91 - $131,543.88 a year
- Full-time
- 6 years
- Research
- Bachelor's degree
9d

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Supplier Quality Engineer
Nifco America, Corp. —Canal Winchester, OH
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Supplier Quality Engineer
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Sr Mgr, QA/Quality Engineer, Device & Combination Products

ESPERION THERAPEUTICS INC
Ann Arbor, MI

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Job Details

$166,500 - $175,000 a year

Benefits

Paid holidays
Health insurance
Paid time off
401(k) matching

Qualifications

Regulatory inspections
ISO standards
Laboratory experience
Laboratory information management systems
GMP
Project management experience in manufacturing
Microsoft Office
Biomedical regulatory compliance
Managing projects
Clinical research inspection readiness
Quality control experience within pharmaceutical industry
Quality audits
Technical Proficiency
Cross-functional communication
Customer complaint resolution
Pharmaceutical manufacturing facility experience

Full Job Description

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, 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, 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).

Quick Apply

Refine Your Search

supplier quality engineer jobs in chelsea, mi

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

Plant Quality Engineer

Supplier Quality Engineer

Quality Engineer II

Quality Systems Engineer

Sr. Global Supplier Quality Engineer

Production Quality Engineer

Quality Engineer

Test Engineer

Impact Safety Test Engineer

Test Engineer A/Sr

Validation Engineer

Supplier Quality - Packaging

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