Quality Engineer IV

Job Summary

A company is looking for a Quality Engineer IV to support compliance processes and product development in the medical device industry.

Key Responsibilities

• Serve as a subject matter expert for hardware and software compliance across various stages of product development
• Lead collaboration with engineering teams to improve compliance processes and coordinate product releases
• Represent the company in audits and inspections, staying informed on international standards and regulations

Required Qualifications

• Minimum of 8 years of experience in a quality environment within the medical device industry
• Bachelor's degree in a relevant scientific, engineering, or related field
• Working knowledge of key industry standards and regulations, including 21CFR 820 and ISO 13485
• Experience implementing IEC 62304
• Preferred certifications: Certified Software Quality Engineer (CSQE) or Certified Quality Engineer (CQE)