What are the responsibilities and job description for the Medical Device Auditor - Georgia position at BSI?
Great that you're thinking about a career with BSI!
About the role:
The British Standards Institution (BSI) is hiring a Medical Device QA Auditor with prior industry experience to join our team in Georgia! This is a home-based role with travel to client sites.
Utilizing their past experience in engineering, design, or quality control of medical devices, combined with rigorous BSI training, our QA Auditors conduct ISO 13485 audits and CE Marking activities for clients to ensure products meet international standards and are go-to-market ready.
The ideal candidate will need hands-on technical experience with medical devices in the following categories: active devices, plastics, and metals.
Medical Device Auditor Responsibilities:
- Deliver BSI's third-party audit services to assigned clients in accordance with all BSI, scheme and regulatory requirements to assure timely, cost effective service delivery that assures satisfaction of our customer needs. Analyze quality systems and assess ISO 13485 and CE Marking
- Manage a portfolio of assigned clients based on geographic location and a match of qualifications and client contract requirements. Client management includes contacting them to schedule the visit, planning the assessment, making appropriate travel plans, conducting assessments, completing reports, and managing results
- Participate in professional development and training opportunities to achieve necessary certifications and statuses
Education/ Qualifications:
- Due to strict regulatory requirements,onlycandidates with Bachelor's degrees incomputer and software technology, biology, chemistry, biochemistry, electrical/electronic/mechanical or bioengineering, human physiology, medicine, physics, or biophysics, will be considered for this role
- A minimum of four years of full-time hands-on (R&D, manufacturing, and/or testing) work experience in the field of medical devices or related sectors
- At leasttwo years in the area of quality management(experience working in an organization governed by regulations and standards)
What we offer:
BSI offers a competitive salary, group-sponsored health and dental, short-term and long-term disability, a company-matched 401k plan, company paid life insurance, 11 paid holidays and 4 weeks paid time off. #LI-DH1
BSI is an Equal Opportunity Employer and we are committed to diversity.
BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.
