Sr. Quality Assurance Manager

TriMas Life Sciences; Clinton Charter Township (MI); On-site; USD 110,000 - 140,000; Full time

Job summary

TriMas Life Sciences seeks a Senior Quality Assurance Manager to lead the QMS strategy from design through manufacturing and post-market activities. You will drive regulatory compliance, CAPA, and continuous improvement while partnering with leaders across functions to sustain a culture of quality.

The role requires on-site presence in Clinton Township, MI, with 8+ years in regulated QA environments and 5+ years in leadership.

Qualifications

• 8+ years experience with FDA 21 CFR Part 820, ISO 13485, ITAR, CAPA, audits, validation, and Quality Management Systems.
• 8+ years of progressive Quality Assurance experience in a regulated ISO13485 plastic injection manufacturing environment.
• 5+ years experience in a leadership role for a quality team.

Responsibilities

• Provide strategic leadership for the Quality Management System (QMS) to ensure ongoing compliance with FDA/ISO standards.
• Lead external quality audits and serve as Management Representative for customer, certification body, and regulatory audits.
• Oversight of QA Department and QA personnel to align quality objectives with business goals.
• Foster a culture of quality, training, and continuous improvement across functions.

Skills

Leadership

Quality Systems

Regulatory Compliance

CAPA

Audits

Training

Education

Bachelor's degree in a technical discipline

Job description

The Senior Quality Assurance Manager is responsible for the strategic leadership, development, implementation, maintenance, and continuous improvement of the Company's Quality Management System (QMS). This role ensures the QMS remains effective, compliant, and aligned with applicable regulatory requirements, including FDA 21 CFR Part 820, ISO 13485:2016, customer requirements, and other applicable standards throughout the product lifecycle—from design and development through commercial manufacturing and post-market activities.

This position provides organizational leadership in quality and regulatory compliance by establishing effective quality processes, driving continuous improvement initiatives, identifying compliance risks, and implementing corrective and preventive actions. The Senior Quality Assurance Manager partners with leaders across all functional areas to foster a culture of quality, accountability, and continuous improvement while ensuring employees receive the training and guidance necessary to maintain compliance.

Serving as the Management Representative and lead for external quality audits, this role is responsible for coordinating and representing the organization during customer, certification body, and regulatory audits. The Senior Quality Assurance Manager also provides leadership and oversight for the Quality Assurance Department, including direct management of Quality Assurance personnel and the Quality Control Manager, ensuring departmental objectives support the organization's quality and business goals.

This role is required to be on-site 5 days a week at the Clinton Township, Michigan location.

• Bachelor’s degree in a technical discipline or equivalent experience.
• 8+ years experience with FDA 21 CFR Part 820, ISO 13485, ITAR, CAPA, audits, validation, and Quality Management Systems.
• 8+ years of progressive Quality Assurance experience in a regulated ISO13485 plastic injection manufacturing environment.
• 5+ years experience in a leadership role for a quality team

About Us

TriMas Life Sciences is a global provider of precision injection-molded components and assemblies for the medical device, diagnostic, pharmaceutical and surgical markets. The company serves key industries, including medical, packaging, industrial and consumer goods, and through our trusted brands, we deliver innovative, high-quality solutions that support our customers from prototype to full-scale production.

Our work enables life-saving technologies and products that improve people’s lives, and we take pride in being part of that purpose everyday.

Why Join TriMas Life Sciences?

At TriMas Life Sciences, we believe our success begins with our people. We are committed to creating an environment where every employee feels valued, supported and inspired to contribute their best work.

When you join our team, you become part of a collaborative and purpose-driven organization committed to:

Supporting Our People

Our employees are the heart of our success. We embrace diversity, encourage collaboration and foster an inclusive workplace built on safety, respect and continuous learning.

Driving Innovation

We invest in technology, automation and process excellence to deliver “part perfect” solutions. Our teams are empowered to develop new ideas while ensuring the highest standards of quality and compliance.

Advancing Healthcare

We partner with our customers to design and manufacture precision-engineered solutions that enable medical innovation, enhance patient care and support better health outcomes worldwide.

Building a Sustainable Future

We are committed to responsible manufacturing, minimizing environmental impact and helping customers bring safer, more sustainable products to market.

We offer competitive benefits, a culture that supports and empowers our people, and opportunities to make a meaningful difference.

If you’re looking for a place where you can grow your career, be challenged and contribute to life-changing innovations, TriMas Life Sciences is the place for you.