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)
Engineer Iv • Dayton, Ohio, United States