Job Summary

An integrated healthcare services and products company is filling a position for a Remote Principal Design Quality Engineer.

Core Responsibilities Include:

• Providing quality support in design, development and changes to medical device products
• Driving successful execution in collaboration with leadership of quality and compliance strategies and annual Quality Goals
• Partnering with R&D and center-led Quality Operations team to drive excellence in product quality and regulatory compliance

Required Skills:

• BS in Engineering and 8+ years of progressive quality engineering/management responsibility
• 5+ years in the medical device industry, or equivalent work experience and/or professional qualifications
• Working knowledge of, & auditing experience to, the FDA Quality System Regulation, ISO 13485, IEC60601, & Medical Device Directive
• Knowledgeable in test methods and standards for the design, verification, and validation of medical device products
• Experienced in product risk management to the requirements of ISO 14971
• Skilled in statistical methods, statistical process control and sampling plans