Sustaining Quality Engineer

Come join our growth-oriented medical device client as they expand their quality engineering team by adding a Sustaining Quality Engineer. The Sustaining Quality Engineer will apply quality engineering principles and problem-solving methods to support product quality, manufacturing processes, regulatory compliance, and continuous improvement within a highly regulated medical device environment.

This role will partner closely with Manufacturing, R&D, Engineering, Operations, Supply Chain, and Quality teams to investigate quality issues, improve processes, maintain quality documentation, and support product and process changes. The ideal candidate has strong hands-on quality engineering experience, technical problem-solving skills, and a solid understanding of quality systems and manufacturing processes.

• Bachelor’s degree in Engineering, Science, or a related technical discipline with 4+ years of relevant Quality Engineering, Manufacturing, or R&D experience; or Master’s degree with 2+ years of relevant experience.
• Demonstrated experience leading root cause investigations, CAPA activities, nonconformance investigations, and material review/disposition processes.
• Experience with statistical analysis and quality tools such as Minitab or similar software.
• Knowledge of process validation and test method development/validation.
• Experience supporting new product introduction, product launches, manufacturing transfers, or production stabilization.
• Strong understanding of statistical process control (SPC), FMEA, risk management, root cause analysis, and structured problem-solving methodologies.
• Experience working within a regulated medical device or similarly controlled manufacturing environment.
• Familiarity with FDA and ISO quality requirements and regulated quality management systems.
• Experience with electromechanical, diagnostic, therapeutic, or other complex medical products is a plus.
• Strong written and verbal communication skills with the ability to work effectively across technical and functional teams.

Responsibilities of the Sustaining Quality Engineer:

• Lead investigations into product, manufacturing, and process-related quality issues.
• Develop and maintain risk management documentation, including process risk assessments and FMEA activities.
• Support manufacturing and engineering activities associated with process and product transfers, including equipment and process qualification.
• Develop and maintain inspection procedures, test methods, sampling plans, and other quality documentation.
• Review and implement changes involving quality procedures, work instructions, test methods, manufacturing processes, product specifications, technical documentation, and labeling.
• Lead supplier evaluation, qualification, and ongoing quality activities.
• Partner with suppliers to resolve quality issues and manage supplier-related changes.
• Establish receiving inspection requirements and associated inspection and test methods.
• Lead CAPA investigations and ensure corrective and preventive actions are completed effectively and on schedule.
• Provide day-to-day quality support to cross-functional engineering and operations teams.
• Support internal and external audits, regulatory inspections, and associated compliance activities.
• Review equipment qualification activities and maintain documentation related to calibration and equipment control.
• Lead nonconformance investigations and resolution activities, including material review and product disposition.
• Support qualification of purchased components and materials and collaborate with inspection teams.
• Review and support environmental monitoring activities where applicable.
• Monitor and report quality metrics to identify trends, risks, and opportunities for improvement.
• Participate in continuous improvement and other quality-related projects as needed.