Quality Engineer

About the role

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. The goal is to:

• Facilitate product safety and compliance
• Consistently meet or exceed customer expectations
• Uphold TriMas Life Sciences principles throughout the product life cycle

Top accountabilities:

• Development of IQ/OQ and PQ protocols and summary reports
• Strong Risk Assessment support to the client, internal groups, and supplier base
• Perform Risk Analysis in accordance with ISO-14971 and FMEA principles

Responsibilities

• Uphold and communicate the purpose, principles, and vision of TriMas Life Sciences
• Facilitate validation activities including client negotiations and technical writing of:
  • Validation Plans
  • Validation Protocol Issue Resolution Reports (initiates appropriate corrective action)
  • Validation Reports for submission to clients
• Provide strong Risk Assessment support to the client, internal groups, and supplier base
• Perform Risk Analysis in accordance with ISO-14971 and FMEA principles
• Develop Quality Plans including layouts, sampling plans, and control dimensions for release per Voice of Customer (VoC) requirements
• Help the organization discern client pharma or device phase of development and assess device application
• Access FDA pharma and medical device websites for up-to-date requirements
• Coordinate quality efforts with clients for customer-specific quality requirements
• Share best practices concerning quality control of the product
• Perform internal audits, including assessments for compliance to 21 CFR 820 and ISO 13485:2016 standards
• Support controlled quality runs for IQ, OQ, and PQ activities
• Ensure all documentation is managed properly, including forms filled out and records stored correctly
• Ensure product is properly identified while updating, including change management back through client approvals
• Manage process changes to quality plans, metrology methods, and other related documents
• Support the Corrective/Preventive action system through identification, containment, investigation, and resolution of Non-Conformance Reports (NCRs)
• Participate in and support third-party and client site audits as needed
• Continually seek new ways to improve Omega Plastics quality processes to support operations
• Perform other tasks as assigned by immediate supervisor and/or manager

Requirements

• A degree in engineering, life sciences, or a related field
• Knowledge of regulatory standards like ISO 13485 and 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 processes 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. 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.