Top 145 Quality assurance manager Jobs in Livonia, 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
4d
Quality Manager
Ford Motor Company —Dearborn, MI
- $138,240 - $261,720 a year
- Online Application
- Engineering
- AWS
- Bachelor's degree
- Paid holidays
- Health insurance
1d
Manager, Quality
McLaren Performance Technologies Inc. and McLaren Engines Inc. —Livonia, MI
- Full-time
- Microsoft Excel
- Microsoft Outlook
- 5 years
- Dental insurance
- Vision insurance
Quick Apply
Sr Manager, Quality Control – Drug Device Combination Products
ESPERION THERAPEUTICS INC —Ann Arbor, MI
- $166,500 - $175,000 a year
- Remote
- Management
- Microsoft Office
- 8 years
- Paid holidays
- Health insurance
Quick Apply
2d
Quality Manager
Exotic Automation & Supply —New Hudson, MI
- $65,000 - $85,000 a year
- Full-time
- 3 years
- Bachelor's degree
- Product management
Quick Apply
12d
Quality Manager (Automotive Experience Required)
Harada Industry of America, Inc. —Novi, MI
- $120,000 - $140,000 a year
- Full-time
- Hybrid work
- Spanish
- Microsoft Excel
- 5 years
- Paid holidays
- Disability insurance
Quick Apply
Food Safety & Quality Assurance Supervisor
DO & CO —Detroit, MI
- $60,000 - $67,000 a year
- Weekends as needed
- Mid-level
- 3 years
- Bachelor's degree
- Health insurance
- Dental insurance
Quick Apply
Project Manager – C&I QA/QC
Utility Energy Services —Detroit, MI
- $90,000 - $110,000 a year
- Full-time
- 5 years
- Engineering
- Master's degree
- Health insurance
- Dental insurance
Quick Apply
9d
Quality Manager-Aerospace
Ventura Aerospace —Wixom, MI
- $105,000 - $120,000 a year
- Full-time
- CAD
- Engineering
- 8 years
- Health insurance
- Dental insurance
Quick Apply
14d
Regional Operations Manager - Detroit, MI
OPENLANE —Detroit, MI
- $65,000 - $70,000 a year
- Full-time
- Remote
- Mid-level
- Driver's License
- Continuous improvement
- Paid parental leave
- Health savings account
Quick Apply
Civil Engineering Project Manager- QA and Inspections
SME —Plymouth, MI
- Microsoft Outlook
- Computer literacy
- Mid-level
- Profit sharing
- Health insurance
Quick Apply
Quality Supervisor
WFQ Inc. —New Hudson, MI
- $23 - $25 an hour
- Full-time
- Background check
- 5 years
- English
- Health insurance
- Dental insurance
Quick Apply
1d
3rd party Quality Control Supervisors
Staff Source Inc —New Boston, MI
- $19 - $22 an hour
- Full-time
- Computer literacy
- Mid-level
- Team management
- Health insurance
- Dental insurance
Quick Apply
2d
Quality Manager
Flex-N-Gate —Warren, MI
- Full-time
- Computer literacy
- Writing skills
- Research
Quick Apply
QUALITY ASSURANCE MANAGER
PRESTIGE STAMPING LLC —Warren, MI
- Full-time
- ERP systems
- Organizational skills
- Training & development
- Paid holidays
- Disability insurance
Quick Apply
Quality Systems Manager
Delta Research —Livonia, MI
- Engineering
- Mentoring
- US work authorization
Quick Apply
Quality Manager
American Rheinmetall —Plymouth, MI
- Background check
- ERP systems
- Senior level
Quick Apply
Plant Quality Manager level 1
Faurecia —Fraser, MI
- $108,000 - $145,000 a year
- 5 years
- Engineering
- English
Quality Engineering Manager
American Rheinmetall —Auburn Hills, MI
- Background check
- Customer service
- Engineering
Quick Apply
8d
Quality Manager
Jing-Jin Electric North America —Farmington Hills, MI
- $107,000 - $134,000 a year
- Analysis skills
- Bachelor's degree
- Mentoring

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quality assurance manager jobs near livonia, mi

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
4 days ago

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
Technical Proficiency
Audit support
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 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, 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).

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Refine Your Search

quality assurance manager jobs in livonia, mi

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

Quality Manager

Manager, Quality

Sr Manager, Quality Control – Drug Device Combination Products

Quality Manager

Quality Manager (Automotive Experience Required)

Food Safety & Quality Assurance Supervisor

Project Manager – C&I QA/QC

Quality Manager-Aerospace

Regional Operations Manager - Detroit, MI

Civil Engineering Project Manager- QA and Inspections

Quality Supervisor

3rd party Quality Control Supervisors

Quality Manager

QUALITY ASSURANCE MANAGER

Quality Systems Manager

Quality Manager

Plant Quality Manager level 1

Quality Engineering Manager

Quality Manager

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