Quality Engineer

TriMas Life Sciences; Clinton Charter Township (MI); On-site; USD 85,000 - 115,000; Full time

Job summary

TriMas Life Sciences is seeking a Quality Assurance Engineering professional to lead validation programs for medical devices and components. You will develop IQ/OQ/PQ protocols, perform risk analyses per ISO-14971, and ensure compliance with 21 CFR 820 and ISO 13485:2016.

This role emphasizes collaboration with clients and internal teams to ensure product safety, traceability, and documentation accuracy throughout the product lifecycle.

Qualifications

• Degree in engineering, life sciences, or related field with knowledge of regulatory standards like ISO 13485, FDA 21 CFR Part 820.
• Strong communication skills: verbal, written, and technical presentations.
• Working knowledge of statistics (e.g. SPC, Red X, Taguchi) and production quality systems.

Responsibilities

• Develop IQ/OQ and PQ protocols and summary reports.
• Perform Risk Analysis per ISO-14971 and FMEA principles.
• Support Quality Plans, validation activities, and audits across client programs.

Skills

Strong communication

Statistics

FMEA

Problem solving

MS Office

Education

Engineering/Life sciences degree

Job description

Acts as the primary advocate for compliance and Quality Assurance Engineering of medical devices and medical device components for the development of Validation programs and program compliance requirements such as Quality Plans, pFMEAs, and process control plans with the goal of 1) facilitating product safety and compliance, 2) of consistently meeting/exceeding customer’s expectations and 3) following and upholding TriMas Life Sciences principles thru-out the product life cycle.

Top accountabilities (no more than 3):

• Development of IQ/OQ and PQ protocols and summary reports
• Strong Risk Assessment support to 1) the client, 2) groups within the organization and 3) supplier-base
• Perform Risk Analysis in accordance with ISO-14971 and FMEA principles
• Quality Plans - layouts, sampling plan, and control dimensions for release per VoC-requirements
• Help the organization discern client pharma or device phase of development and assess device application
• Coordinate quality efforts with client for customer specific quality requirements
• Share best practices concerning the quality control of the product

Authority:

• Validation protocol approval
• Completion and approval of risk assessments support NCRs, CCRs and SCCs
• Performance of internal audits and citing nonconformances

Specific Responsibilities:

• Uphold and communicate the purpose, principles, and vision of TriMas Life Sciences
• Facilitates Validation activities such client negotiations and technical writing of:
• Validation Plans
• Validation Protocol Issue Resolution Reports- initiates appropriate corrective action
• Validation Reports for submission to clients
• Strong Risk Assessment support to 1) the client, 2) groups within the organization and 3) supplier-base
• Perform Risk Analysis in accordance with ISO-14971 and FMEA principles.
• Quality Plans - layouts, sampling plan, and control dimensions for release per VoC-requirements
• Help the organization discern client pharma or device phase of development and assess device application
• Access FDA pharma and medical device web site for up-to-date requirements
• Coordinate quality efforts with client for customer specific quality requirements
• Share best practices concerning the quality control of the product
• Performance of internal audits which includes performing assessments for compliance to 21 CFR 820 and ISO 13485:2016 standards
• Support controlled quality runs for IQ, OQ and PQ activities
• Ensures all documentation is managed properly - forms are filled out and records properly stored
• Product is properly identified while updating - includes change management back thru client approvals
• Manages process changes to quality plan, metrology methods and other related documents
• Support the Corrective/Preventive action system through the identification, containment, investigation and resolution of NCRs.
• Participates and support third party and client site audits as needed
• Continually seeks out new ways to improve Omega Plastics quality processes to support our operations
• Other tasks as assigned by immediate supervisor and/or manager.

Qualifications:

• A degree in a degree in engineering, life sciences, or a related field, along with knowledge of regulatory standards like ISO 13485, FDA 21 CFR Part 820.
• Strong communication skills: verbal, written and technical presentations.
• Working knowledge of statistics (e.g. Red X, Taguchi Methods, Disciplined Problem Solving, SPC Gage R & R) and production quality systems.
• Demonstrated ability to track improvement process through performance data. Strong organizational skills and the ability to successfully complete multiple tasks within established and changing deadlines.
• Excellent problem resolution skills. Working knowledge of Microsoft Word, Excel, and PowerPoint.

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 every day.

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.