Senior Quality Assurance Manager
Listed on 2026-10-16
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
Senior Quality Assurance Manager / Quality Assurance Manager
$160,000 - $180,000 + Profit Sharing (10%) + Training (Tuition Reimbursement / Udemy) + Development + On-site role
Site near Detroit, MI - (Commutable from: Sterling Heights, Warren, Roseville, Macomb, Mount Clemens, Clinton Township, Troy, Royal Oak)
Are you a Quality Assurance Manager with regulated manufacturing experience looking to step into a senior, site-leading role where you will own the Quality Management System and be recognized as the go-to person for audits, compliance, and continuous improvement?
On offer is a permanent, on-site position with a well-established manufacturer that invests in training and development (tuition reimbursement, certifications, and Udemy/upskilling), giving you real ownership and influence across the full product lifecycle from design through commercial manufacturing.
Established in 1980 and operating across multiple North American plants, this business is known for producing high-quality plastic components and precision manufacturing solutions for demanding end markets. As a result of continued requirements in quality and regulatory compliance, they are now looking to add a Senior Quality leader at the Clinton Township site.
In this role you will lead the development, implementation and continual improvement of the QMS, drive CAPA and validation activity, partner with cross-functional leaders, and act as the Management Representative for external customer, certification body and regulatory audits.
This role would suit a senior Quality professional looking for increased ownership, technical challenge and long-term development within a stable organization.
The Role:- Lead and continuously improve the site Quality Management System (QMS)
- Drive compliance to FDA 21 CFR Part 820 and ISO 13485:2016 requirements
- Lead external audits and act as the Management Representative
- On-site role, 5 days per week (8am-4pm)
- Quality Assurance leadership experience in regulated manufacturing (ISO 13485 / FDA 21 CFR Part 820)
- Background in CAPA, audits and validation within a quality system
- Comfortable leading a quality team and partnering cross-functionally
Reference Number: BBBH
280955
We are an equal opportunities company and welcome applications from all suitable candidates.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).