Principal Design Quality Engineer

Location: Boston (Hybrid)

A leading biotech is seeking a Principal Design Quality Engineer to lead design quality functions for their leading combination device. The Principal Design Quality Engineer will primarily be responsible for providing QA support to Design and Development and for product related functions.

Responsibilities:

• Lead Design functions - design inputs/outputs, risk management, design V&V testing, design transfer, etc.
• Support for design-related continuous improvement, design changes, and market expansion
• QA oversight of root cause investigations, CAPAs, change controls, complaint trending, and post-market surveillance activities
• QA support for product related audits, regulatory inspections, and regulatory submissions
• Work with component suppliers - change management and supplier audit support

Qualifications:

• 10 years of relevant experience within medical device, combination product experience preferred
• Experience leading Design Quality through the entire product lifecycle
• Experience with design history, human factors, and risk management files

If this sounds interesting, please don't hesitate to apply!