Quality Engineer - Injection Molding | Med Devices

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.