Senior Quality Control Engineer

Biomerics is a contract manufacturing, laser processing, and finishing provider that supplies a wide range of industries with a strong commitment to customer service. They specialize in the most challenging machined and micromachined components, including those used in interventional and medical robotics applications, and offer Swiss machining with integrated laser cutting on precision medical tubing. Their core competency lies in smaller medical components produced with high accuracy and repeatability, with additional 5‑axis milling capabilities.

Senior Quality Control Engineer

Monroe, CT

Full‑time

• Participate in product development teams, providing quality input and support
• Develop and implement control plans, master validation plans, and inspection procedures
• Develop validation strategies, ensuring all applicable requirements are met—from planning and protocol definition to execution, analysis, reporting, and approval
• Lead the development and results analysis of validation plans (IQ/OQ/PQ), test method validation (TMV), Gage R&R, and test protocols to qualify and validate existing product designs, processes, and equipment
• Determine and recommend sampling plans, equipment requirements, measurement techniques, and training requirements to ensure specific quality levels
• Support new product introductions and process changes
• Assist manufacturing engineering in creating, releasing, and maintaining DHR, bill of materials, and manufacturing specifications
• Review and approve product documentation
• Lead preparation of risk management files and reports for product releases, and take primary responsibility for risk management activities from conception through commercialization
• Ensure risk management processes are followed and documented
• Ensure compliance with Biomerics quality standards, policies, and procedures
• Support external customer and regulatory agency audits
• Maintain consistent dialogue with customers and teammates to ensure clear communication and expectations
• Lead investigations for nonconformances and customer complaints
• Use problem‑solving tools to analyze and identify root causes and implement corrective actions
• Identify opportunities for process improvement and implement solutions
• Monitor quality performance metrics and trends
• Provide leadership and mentoring to other quality team members
• Promote a culture of quality and foster a culture of compliance and continuous improvement

• Bachelor’s degree in Engineering, Quality, or a related field or equivalent experience
• 5+ years of experience in quality engineering within a medical device manufacturing environment
• Working knowledge of process development and validation
• Strong knowledge of quality systems and regulations (e.g., FDA QSRs, ISO 13485, ISO 14971)
• Experience with root‑cause analysis, CAPA, and risk management
• Familiarity with statistical tools and methods
• Knowledge of medical device manufacturing processes
• ASQ certifications (e.g., CQE, CQA) are preferred
• Strong problem‑solving and analytical skills
• Excellent communication and interpersonal skills
• Proficiency in Microsoft Office and Minitab
• Ability to work independently and as part of a team
• Strong organizational and project‑management skills

Medical/Dental/Vision insurance; short‑term disability; long‑term disability; life insurance; paid vacation days; paid holidays; 401(k)

Minority, Female, Protected Veteran, Individual with Disabilities are encouraged to apply.