Quality Assurance Engineer

Responsibilities

• Lead Design Control initiatives to develop and maintain appropriate Design History File (DHF) documentation
• Review and approve new product documentation, design control documents, and protocols
• Collaborate with Project Management to optimize Design Control and Sustaining Quality Engineering processes
• Serve as the organizational subject matter expert for Design Control and deliver related training
• Support CAPA and Risk Management activities to ensure compliance with international standards and regulations
• Interface with cross-functional departments including Engineering, Operations, and Regulatory Affairs to resolve design ambiguities

Requirements

• BS degree in Engineering, Science, Computer Systems, Quality Management, or equivalent experience
• 2-5 years of Quality Assurance experience within an FDA, ISO, or other highly regulated environment
• Proven experience in the development and implementation of effective Design Control Systems
• Working knowledge of FDA 21 CFR Part 820 and ISO 13485
• Working knowledge of ISO 14971 (Risk Management) and ISO 62304 (Software Life Cycle)
• Proficiency in Microsoft Office (Word, Excel, Access, PowerPoint)
• Demonstrated experience organizing and maintaining large, complex documentation sets

Preferred Qualifications

• Familiarity with EN 60601 safety requirements for medical electrical systems
• Experience with structured phase-gate product development processes
• Strong verbal and written communication skills with the ability to collaborate across multiple organizational levels
• Ability to prioritize tasks and maintain accurate records in a high-energy environment

About the Company

Insulet Corporation is a global medical technology company dedicated to enabling people with diabetes to enjoy simplicity, freedom, and healthier lives through the Omnipod® product platform. We leverage innovative, wearable, and waterproof technology to improve patient outcomes and break down barriers to healthcare access.