Senior Quality Engineer

We are seeking a Senior Quality Engineer to support the manufacturing and ongoing quality of complex electronic, electrical, and electromechanical medical devices within an FDA-regulated environment.

The ideal candidate will have 10+ years of Product Quality Engineering experience , a strong Electrical/Electronics Engineering background , and proven expertise in root cause analysis, CAPA, nonconformance investigations, and manufacturing quality .

Key Responsibilities

• Lead investigations into product quality issues, nonconformances, and manufacturing defects.
• Perform root cause analysis and develop effective corrective and preventive actions (CAPA).
• Partner with Electrical, Electronics, Manufacturing, Operations, and Quality teams to resolve production issues.
• Analyze quality trends, manufacturing data, and product performance to identify improvement opportunities.
• Support product and process improvements throughout the product lifecycle.
• Provide quality support for engineering and design changes.
• Review and maintain manufacturing and quality documentation.
• Ensure products and processes meet FDA and applicable quality system requirements.
• Drive continuous improvement initiatives focused on product quality, reliability, and manufacturing performance.
• Collaborate with cross-functional teams to identify and mitigate quality risks.
• Support complex investigations and ensure timely and effective closure of quality issues.

Required Qualifications

• 10+ years of Product Quality Engineering experience .
• Strong Electrical/Electronics Engineering background.
• Experience supporting electronic, electrical, or electromechanical products .
• Experience in medical device or aerospace manufacturing environments.
• Strong experience with root cause analysis, CAPA, nonconformances, and production support .
• Experience working in an FDA-regulated environment .
• Strong problem-solving, analytical, and communication skills.
• Must be willing to work 100% onsite in Massachusetts .
• Must be able to provide professional references .

Preferred Qualifications

• Experience with Class II/III medical devices .
• Experience supporting CT scanners, diagnostic imaging systems, patient monitoring equipment , or other complex electronic medical devices.
• Knowledge of ISO 13485 .
• Experience with Arena QMS .
• Experience using Minitab for quality and statistical analysis.