Quality Engineer

TriMas Corporation; Michigan; On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Job summary

Omega Plastics Inc is seeking a Quality Engineer to lead compliance and QA engineering for medical devices and components, developing validation programs and quality plans to ensure safety and customer satisfaction throughout the product lifecycle.

The role emphasizes IQ/OQ/PQ protocol creation, risk assessment, and adherence to ISO 13485 and FDA requirements, with on-site collaboration and strong documentation practices.

Qualifications

• Requires degree in engineering, life sciences, or related field with knowledge of regulatory standards like ISO 13485 and FDA Part 820.
• Strong communication skills: verbal, written, technical presentations.
• Experience with statistics (SPC, Red X) and production quality systems.

Responsibilities

• Develop IQ/OQ and PQ protocols and summary reports.
• Support risk assessment for clients and internal teams; coordinate with supplier base.
• Perform risk analysis in accordance with ISO-14971 and FMEA principles.
• Coordinate quality efforts with clients for specific quality requirements.
• Support internal audits and ensure 21 CFR 820 and ISO 13485:2016 compliance.

Skills

Quality Assurance

Risk assessment

Regulatory compliance

Process validation

Documentation

Education

Engineering or life sciences degree

Tools

ISO 13485

FDA 21 CFR Part 820

FMEA

Job description

Quality Engineer

Company: Omega Plastics Inc

Primary Location: 24401 Capital Blvd, Clinton Township, MI 48036 USA

Workplace Type: On-site

Employment Type:Salaried | Full-Time

Function: Quality

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Main Duties & Responsibilities

Position Summary:

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 planswith 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.

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.

Qualifications

Qualifications and Skills:

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.

Benefits

Benefit offerings include Medical Insurance and Prescription Drugs, Dental Insurance, Vision Insurance, Flexible Spending Accounts, Life Insurance, Short-Term Disability, Long-Term Disability Insurance (for eligible employees), Employee Assistance Plan (EAP), Paid Time Off (may include vacation and sick time), Retirement Program, and Other Voluntary Benefits.