Senior Design Quality Engineer - On-Site Medical Devices

CooperSurgical; Trumbull (CT); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical coverage

401(k)

Parental leave

Fertility benefits

Paid time off

Job summary

CooperSurgical is looking for a Senior Staff Design Quality Engineer in Trumbull, CT. The role focuses on ensuring compliance and effectiveness of medical devices while providing guidance and mentorship on quality engineering methodologies.

The ideal candidate will have extensive experience in FDA regulations, design controls, and risk management principles, and will work cross-functionally with teams to drive quality initiatives. A strong educational background in Science or Engineering is required, along with a certification in Quality Engineering.

Qualifications

• 10+ years experience in Quality Engineering in the medical device industry.
• Hands-on experience in medical device product development.
• Strong analytical and problem-solving skills with acute attention to detail.

Responsibilities

• Lead quality initiatives for product and process development.
• Mentor cross-functional teams on quality engineering.
• Ensure compliance with FDA and international standards.

Skills

FDA QMSR knowledge

Medical device design controls

Risk management principles

Project management skills

Interpersonal skills

Education

Bachelor's Degree in Science or Engineering

Certification in Quality Engineering

Tools

Excel

PowerPoint

Word

Job description

CooperSurgical is looking for a Senior Staff Design Quality Engineer in Trumbull, CT. The role focuses on ensuring compliance and effectiveness of medical devices while providing guidance and mentorship on quality engineering methodologies.

The ideal candidate will have extensive experience in FDA regulations, design controls, and risk management principles, and will work cross-functionally with teams to drive quality initiatives. A strong educational background in Science or Engineering is required, along with a certification in Quality Engineering.