Quality Engineer

About Trident Manufacturing

Trident Manufacturing is an ISO 13485 certified medical device contract manufacturer of sterile and non-sterile Class I and Class II devices. We combine the discipline and efficiency of automotive manufacturing with the quality and compliance requirements of the medical device industry. Our capabilities include early stage development all the way through completely packaged devices.

Our philosophy is simple: Building It Better For Less.

That means building quality into our processes, eliminating waste and continually improving how we operate.

The Opportunity

We are looking for a Quality Engineer who understands how products are made, why processes fail and how to make them more reliable.

This is a manufacturing focused role for someone who enjoys being on the production floor, investigating problems, working with people and implementing improvements that produce measurable results.

Accurate documentation and regulatory compliance are essential. Equally important is the ability to look beyond the paperwork, understand what is happening in the process and help prevent the next defect.

You will work closely with Production, Engineering, Project Management and Operational Excellence to support existing manufacturing operations and new program launches.

Success means more than closing an action item. It means proving the solution works and preventing the problem from coming back.

What You Will Do

Investigate problems and drive corrective action.
Lead assigned investigations into component, assembly and finished product nonconformances. Use structured methods such as 8D, 5 Why and cause and effect analysis to identify root causes. Coordinate appropriate containment, implement corrective actions with the responsible departments and verify their effectiveness.

Strengthen manufacturing process controls.
Translate approved drawings, specifications and customer requirements into clear inspection plans, test methods and production quality controls. Work with Manufacturing and Engineering to improve fixtures, mistake proofing, work instructions and process consistency. Implement changes through approved change control and validation procedures.

Use data to improve performance.
Analyze scrap, rework, first pass yield, inspection results and recurring defects. Identify patterns, prioritize meaningful improvements and measure results. Apply statistical process control, process capability analysis and measurement system studies where appropriate.

Support new programs and validation.
Participate from program kickoff through process development, validation and production handoff. Support process risk assessments, PFMEAs, control plans, equipment and process qualification activities, and test method validation. Help confirm that processes and measurement methods can reliably meet requirements before routine production.

Work with customers and suppliers.
Support supplier quality investigations, incoming material issues and assigned customer complaints. Communicate technical requirements clearly, document findings and follow through on corrective actions. Help ensure purchased components and finished devices consistently meet approved specifications.

Maintain disciplined quality systems.
Prepare clear, accurate investigation reports, inspection instructions, validation documentation and quality records. Participate in Material Review Board activities and support internal, customer and regulatory audits. Help maintain traceability and compliance with applicable ISO 13485 and FDA Quality Management System Regulation requirements. U.S. Food and Drug Administration

What You Bring

• Three or more years of relevant experience in manufacturing quality engineering or a closely related technical manufacturing role.
• Strong technical and mechanical aptitude, including the ability to understand assembly processes, read engineering drawings and specifications, interpret tolerances and use appropriate inspection equipment.
• Demonstrated problem solving experience, with examples of identifying root causes, implementing corrective actions and verifying lasting improvements.
• Working knowledge of quality tools, including process risk analysis, control plans, statistical analysis, process capability and measurement system analysis.
• A degree in engineering or a related technical discipline, or equivalent practical experience, supported by clear technical writing, data analysis and communication skills.

Medical device manufacturing experience, ISO 13485 knowledge and process validation experience are strongly preferred. Candidates with strong automotive or other precision manufacturing quality backgrounds are also encouraged to apply.

Experience with APQP, PPAP, Lean manufacturing, Six Sigma, Minitab, electronic quality systems or ERP systems is valuable. ASQ Certified Quality Engineer or relevant Six Sigma certification is a plus.

The Person Who Will Succeed Here

You take ownership and follow through. You are comfortable working directly with operators, reviewing a process at the workstation and asking questions until you understand what is actually happening.

You know when immediate containment is necessary, but you do not mistake containment for a permanent solution.

You communicate clearly, organize your work and escalate obstacles early. You can challenge a process constructively without blaming the people performing it.

Most importantly, you want to keep developing your technical skills, take on meaningful responsibility and contribute to a stronger manufacturing operation.

Why Trident?

This is an opportunity to make a visible impact in a medical device manufacturing business where quality, technical capability and execution matter.

You will work closely with experienced leaders across the company, contribute to new programs and help improve the processes behind existing products. There is room to expand your responsibilities through demonstrated performance and continued development.

At Trident, no department succeeds alone. We value collaboration, disciplined execution, continuous improvement and people who take pride in getting things done correctly.

When applying, include a brief example of a manufacturing quality problem you helped solve, what changed and how you verified the result. Please do not include confidential information from another employer.

TRIDENT MANUFACTURING

BUILDING IT BETTER FOR LESS.

Pay: $70,000.00 - $95,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Vision insurance

Work Location: In person