Senior Quality Engineer - Medical Devices, Design Controls

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

Job summary

Resonetics is seeking a Sr. Quality Engineer to join its Quality Assurance team in the US.

The role focuses on implementing and maintaining the QMS for medical device development, ensuring compliance with regulatory requirements and design controls, risk management, and post-market activities. The individual will lead quality activities across design, development, manufacture, and release, with responsibility for CAPA, change control, audits, and DHF/Device Master Records, reporting to the

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.
• Strong attention to detail, organization, and verbal and written communication skills.
• Ability to interact with client companies in a professional manner and lead verification/validation activities.
• Organized and able to self-manage project tasks.
• Proficiency in Word, Excel, and PowerPoint.
• Ability to work under pressure, manage multiple projects, and meet deadlines.
• Ability to read and understand regulations, standards, and procedures.
• Experience with analytical instrument calibration preferred.

Responsibilities

• Responsible for assuring product quality, safety and effectiveness and conduct failure investigations of customer complaints.
• Ensure project teams follow QMS and regulatory standards throughout development.
• Collaborate with development engineers to update Design Controls documentation.
• Author protocols or support qualification/validation in design control deliverables.
• Perform risk assessments and implement corrective actions (CAPA).
• Lead and mentor on DHF/Device Master Record documentation and planning.
• Interact with customers and suppliers to ensure two-way information flow; conduct supplier audits as needed.
• Maintain product/process specifications, standards, and QMS documentation.
• Manage document control and ensure compliance across all processes.
• Provide statistically valid sampling plans and design of experiments support.
• Support training programs and maintain training records.

Skills

Lean Six Sigma

Technical writing

Communication

Attention to detail

Regulatory knowledge

Project management

Client interaction

Quality Engineering

Education

Bachelor's degree or equivalent experience

Tools

Word

Excel

PowerPoint

Job description

Resonetics is seeking a Sr. Quality Engineer to join its Quality Assurance team in the US.

The role focuses on implementing and maintaining the QMS for medical device development, ensuring compliance with regulatory requirements and design controls, risk management, and post-market activities. The individual will lead quality activities across design, development, manufacture, and release, with responsibility for CAPA, change control, audits, and DHF/Device Master Records, reporting to the