Senior Quality Engineer - Medical Devices & QMS

Resonetics; Bethel (CT); On-site; USD 78,000 - 124,000; Full time

Job summary

Resonetics in Bethel, CT is seeking a Sr. Quality Engineer to drive the QMS, support medical device design, development, manufacture and release with a focus on design controls, validation, risk management and post-market activities.

You will lead CAPA, risk management, design verification, supplier quality, training, and documentation, collaborating with cross-functional teams to ensure regulatory readiness and continuous improvement.

Qualifications

• 5+ years of experience in a Quality Engineering role.
• Bachelor’s degree or equivalent experience.
• Lean/Six Sigma experience.
• Demonstrated technical writing and communication skills.
• Ability to lead product verification & validation activities.
• Ability to read and understand regulations, standards, and procedures.

Responsibilities

• Responsible for assuring product quality, safety and effectiveness, and conduct failure investigations of customer complaints.
• 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 as intended.
• Responsible for timely Corrective and Preventative Actions (CAPA), change control and notification, internal and supplier audits, product release, document control, design control process and DHF/DMR.
• Mentor junior engineers on quality system requirements.

Education

Bachelor's degree or equivalent experience

Tools

Word

Excel

PowerPoint

Job description

Resonetics in Bethel, CT is seeking a Sr. Quality Engineer to drive the QMS, support medical device design, development, manufacture and release with a focus on design controls, validation, risk management and post-market activities.

You will lead CAPA, risk management, design verification, supplier quality, training, and documentation, collaborating with cross-functional teams to ensure regulatory readiness and continuous improvement.