Remote Principal Design Quality Engineer

Location: Nationwide

Compensation: To Be Discussed

Staff Reviewed: Tue, Jun 01, 2021

This job expires in: 14 days

Job Category: Information Technology

Remote Level: 100% Remote

Weekly Hours: Full Time

Employer Type: Employer

Career Level: Experienced

Education Level: Bachelors

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

COMPLETE JOB DESCRIPTION

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