Senior Quality Assurance Manager

Rise Technical; Detroit (MI); Sur place; USD 160 000 - 180 000; Plein temps

Avantages offerts par ce poste

Profit Sharing (10%)

Tuition Reimbursement

Udemy courses

On-site role

Development opportunities

Résumé du poste

Rise Technical is seeking a Senior Quality Assurance Manager for an on-site role near Detroit, MI. You will own the Quality Management System, drive CAPA and validation, and lead audits and regulatory compliance across the site.

You will partner with cross-functional leaders and manage a QA team in a regulated manufacturing environment (ISO 13485 / FDA 21 CFR Part 820), delivering continuous improvement and long-term development within a stable, growing manufacturer.

Qualifications

• Leadership experience in QA within regulated manufacturing.
• Experience with CAPA, audits and validation in a QA system.
• Experience leading cross-functional teams.

Responsabilités

• Lead the site Quality Management System (QMS) development and continual improvement.
• Drive CAPA and validation activities.
• Represent the site in external audits and regulatory bodies.
• Partner with cross-functional leaders and QA team.

Connaissances

QA leadership

Regulated manufacturing

CAPA management

Audits & validation

Cross-functional leadership

Description du poste

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)

The Person:

• 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: BBBH280955

We are an equal opportunities company and welcome applications from all suitable candidates.