Job Summary

A healthcare company is filling a position for a Remote Principal Design Quality Engineer.

Core Responsibilities of this position include:

• Partnering with R&D and center-led Quality Operations team to drive excellence in product quality
• Coordinating or leading design quality-related product complaints investigations
• Ensuring compliance to design control and risk management procedures

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 and auditing experience per the FDA Quality System Regulation, ISO 13485, IEC60601, and Medical Device Directive
• Experienced in product risk management to the requirements of ISO 14971
• Skilled in statistical methods, statistical process control and sampling plans