Senior Quality Engineer

Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. With rapid expansion across all our locations, we continue to push the boundaries of technology while fostering a dynamic, employee-centered culture. Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micro-manufacturing and being part of something bigger.

The Sr. Quality Engineer is a key contributing member of the Quality Assurance team, working to implement and maintain the Quality Management System (QMS) to ensure that the activities of the company are performed in compliance with the QMS and applicable regulatory requirements. The individual also serves as a key member of product development teams to perform activities related to design, development, manufacture, and release of medical devices, including, but not limited to, design controls, validation (design, process, and/or software), risk management, design verification, and post-market activities.

This person also works to identify deficiencies in quality system and device performance and recommend and implement corrective and preventive actions. This role reports to the Director of Quality Assurance and Regulatory Affairs. Join Resonetics and be part of a team that’s redefining medical device manufacturing. If you’re passionate about innovation and thrive in a fast-paced environment, we’d love to hear from you.

Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. With rapid expansion across all our locations, we continue to push the boundaries of technology while fostering a dynamic, employee-centered culture. Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micro-manufacturing and being part of something bigger.

The Sr. Quality Engineer is a key contributing member of the Quality Assurance team, working to implement and maintain the Quality Management System (QMS) to ensure that the activities of the company are performed in compliance with the QMS and applicable regulatory requirements. The individual also serves as a key member of product development teams to perform activities related to design, development, manufacture, and release of medical devices, including, but not limited to, design controls, validation (design, process, and/or software), risk management, design verification, and post-market activities.

This person also works to identify deficiencies in quality system and device performance and recommend and implement corrective and preventive actions. This role reports to the Director of Quality Assurance and Regulatory Affairs. Join Resonetics and be part of a team that’s redefining medical device manufacturing. If you’re passionate about innovation and thrive in a fast-paced environment, we’d love to hear from you.

• Responsible for assuring product quality, safety and effectiveness, and conduct failure investigations of customer complaints, as required.
• Ensure project teams are utilizing Resonetics Quality Systems and appropriate regulations and industry standards throughout the product development process.
• Collaborate with the development engineering team(s) to create and/or update documentation to support Design Controls.
• Author protocols or provides support in performing qualification validation protocols in support of design control deliverables.
• Conduct risk assessments of the design to determine ability to function…