Sr Quality Engineer - Exempt

Senior Quality Engineer

Join our dynamic team in North Haven, CT, where you can contribute to shaping the future of healthcare. As a Senior Quality Engineer, you will support new product development for Surgical Instruments. This role involves working closely with a cross-functional core team to drive product quality and continuous improvement.

• Risk Management (Hazard Analysis, DFMEA, UFMEA)
• Design Verification Authoring and Execution
• General NPD QE skillset (Change control, CAPA, ISO 13485 understanding)

• Actively participate in the product development cycle by reviewing project documentation, participating in product risk assessments, and developing verification and validation testing requirements.
• Assess overall product risk by facilitating the development of risk management tools such as risk management plans, hazard identification, and complaint analysis.
• Collect, analyze, and interpret statistical data, providing reports to management as required.
• Contribute to Design and Process Validation initiatives by planning and reviewing validation and qualification activities.
• Provide solutions to a wide range of challenges, working independently to develop imaginative and practicable solutions.

• B.S. degree in Engineering, Math, Physical Science, or equivalent field with 5 years of work experience in engineering or Quality.
• Preferred: M.S. degree in Engineering, Math, Physical Science, or equivalent field with 4 years of work experience in engineering or Quality.

• Fundamental understanding of electro-mechanical designs and manufacturing processes.
• Experience in a regulated industry.
• Experience with Minitab or similar statistical analysis tools.
• Good interpersonal skills and ability to work effectively in a team environment.
• Strong attention to detail and ability to prioritize multiple projects.

• ASQ Certified Quality Engineering (CQE)
• Knowledge of and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO
  13485, 14971, and 60601 requirements.
• Understanding of software and hardware interface.

Join us in North Haven, CT, and be part of a team that is pushing the limits of technology to change healthcare worldwide. Together, we can make a difference.