Quality Engineer - Injection Molding | Med Devices

Quality Engineer – Medical Devices & Injection Molding

Northwest Connecticut | On-Site
$100,000–$115,000 | Full Benefits
ISO 13485 | Quality Engineering | CAPA | Manufacturing Quality

Make Quality a Competitive Advantage

We’re partnered with an established precision manufacturer serving medical, life-science, and other quality-critical markets. As the organization expands, it is adding an experienced Quality Engineer who can strengthen product quality, support manufacturing, and help technical teams solve problems before they reach the customer.

This is not a desk-only compliance position. You’ll work closely with manufacturing and engineering teams, apply sound quality practices on the production floor, and help ensure important products are built safely, consistently, and correctly.

The Opportunity

The Quality Engineer will support both established production and new manufacturing programs in a regulated environment. You’ll translate customer and regulatory expectations into practical controls, analyze performance, investigate problems, and drive improvements across internal operations and the supply base.

What You’ll Do

• Establish practical quality controls for molded products and manufacturing processes.
• Review specifications, drawings, process risks, and inspection requirements.
• Support qualification of new products, equipment, tooling, and process changes.
• Analyze dimensional, process, defect, and capability data to identify risk.
• Lead investigations into internal defects, customer concerns, and recurring variation.
• Develop and verify corrective and preventive actions.
• Partner with manufacturing teams to reduce scrap and improve process consistency.
• Support customer, regulatory, and quality-system audits.
• Work with suppliers to address material, component, and performance concerns.
• Provide quality guidance during new-product launches and manufacturing changes.
• Maintain clear, accurate, and audit-ready engineering records.
• Train employees on quality requirements, problem solving, and defect prevention.
• Promote ownership, continuous improvement, and sound risk-based decisions.

What We’re Looking For

• Bachelor’s degree in Engineering or a closely related technical discipline.
• At least 3–5 years of quality-engineering experience in medical device manufacturing.
• Meaningful experience supporting plastic injection-molding operations.
• Working knowledge of ISO 13485 and FDA-regulated quality requirements.
• Experience with CAPA, root-cause analysis, risk management, and process validation.
• Ability to interpret drawings, specifications, inspection results, and statistical data.
• Familiarity with SPC, capability analysis, measurement systems, and quality tools.
• Experience supporting audits, suppliers, customers, and cross-functional projects.
• ASQ certification is valued but not required.
• Strong judgment, communication, organization, and hands-on problem-solving ability.

Why Join?

$100,000–$115,000 based on experience
Comprehensive benefits package
Stable organization expanding its technical capabilities
Work connected to important, quality-critical products
Direct influence on manufacturing and customer outcomes
Broad exposure across Engineering, Operations, and suppliers
Collaborative culture that values practical problem solving
Professional and technical growth opportunities

Location

This is a fully onsite opportunity in Northwest Connecticut. Occasional supplier or customer travel may be required. Candidates must live within commuting distance or relocate independently. Relocation assistance is not available.

Applicants must be authorized to work in the United States. No current or future employment sponsorship is available.

Make an Impact Through Quality

If you’re a Quality Engineer who understands medical device manufacturing and injection molding, we want to hear from you.

Please submit a resume for confidential consideration. Only qualified applicants who provide a resume will be contacted. Salary is dependent on experience.

Ross DeRosier | ross.derosier@gogpac.com
(920) 873-5538
gpac

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All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.

GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States since 1990. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.