Quality Engineer - Medical Device Manufacturer Well-established manufacturer serving the medical device industry is looking for a Quality Engineer to join their team in the greater Rochester, NY area. You'll play a key role in maintaining and advancing quality systems within an FDA regulated manufacturing environment. This is a hands-on position for someone who enjoys owning validation work end-to-end and being a trusted technical resource on the plant floor. What You'll Do

• Develop and/or execute IQ/OQ/PQ and process-validation protocols
• Support and help lead internal quality audits; serve as a technical resource during external/regulatory audits
• Drive root cause investigations and CAPA activities
• Apply statistical tools (e.g., process capability analysis) to monitor and improve process performance
• Author and revise SOPs and quality documentation
• Partner cross-functionally with Manufacturing, Engineering, and Regulatory teams to maintain compliance with FDA and

ISO 13485

requirements What You Bring

• Bachelor's degree in engineering, Quality, or a related technical field
• 2-5 years of quality engineering experience in an FDA-regulated manufacturing environment
• Hands-on experience developing or executing IQ/OQ/PQ or process-validation protocols
• Working knowledge of ISO 13485 and FDA quality system requirements
• Strong problem-solving skills and comfort working directly on a manufacturing floor
• ASQ certification (CQE) or Lean Six Sigma training a plus, not required Compensation & Location Competitive salary and benefits package; based on-site in the greater Rochester, NY area.

Relocation not provided. Local candidates preferred.

Pay:

$80,000.00 - $95,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Employee discount Flexible schedule Flexible spending account Health insurance Health savings account Life insurance Paid time off Parental leave Professional development assistance Referral program Vision insurance

Work Location:

In person