Quality Engineer

Location:

Marlborough, MA (Locals are highly preferred)

Client is seeking a Quality / Process Validation Engineer to support manufacturing and quality initiatives in a regulated medical device environment. This role will focus on process validation execution (IQ/OQ/PQ/TMV), statistical analysis, investigations, and cross-functional collaboration to ensure products and processes meet internal and regulatory requirements.

• Lead and support Process Validation activities including IQ, OQ, PQ, and TMV (Must have)
• Conduct root cause investigations using:
• FMEA
• Perform statistical analysis using tools such as:
• Gage R&R and 8D
• Capability Analysis
• ANOVA
• (Minitab experience is a plus)
• Read and interpret technical drawings, specifications, and manufacturing documentation
• Support audit readiness and participate in internal/external audits as needed
• Create, review, and maintain documentation aligned with ISO 13485 and medical device compliance requirements
• Ensure corrective and preventive actions (CAPA) are properly documented, executed, and sustained
• Drive continuous improvement initiatives to improve quality, yield, and compliance

• Strong self-motivation with the ability to adapt to change in a fast-paced environment
• Ability to work cross-functionally and as part of a project team
• Ability to read and interpret technical drawings
• Experience in ISO 13485 regulated industry
• Strong attention to detail and organizational skills
• Hands-on experience supporting audit processes (internal or external audits)
• Strong knowledge of root cause investigation tools (FMEA, Fishbone, 5 Why, 8D)
• Process Validation experience (IQ/OQ/PQ/TMV)