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 New Jersey! 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 in organic chemistry or equivalent technical application such as cosmetics, refinery, distillation, molecular characterization, as well as experience with medical devices in the following categories: IVD, Organic Chemistry, Human and/or Animal Tissue, or Microbiology.

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 management systems by assessing, as applicable, against ISO 13485, ISO 9001, CE Marking (MDD, MDR) and MDSAP regulations
• 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, only candidates with a Bachelor of Science degree in chemistry, biochemistry, biology, microbiology, bioengineering, human physiology, medicine, or biophysics will be considered for this role
• At least two years in the area of quality management (experience working in an organization governed by regulations and standards)
• A minimum of four years of full-time hands-on work experience in the field of medical devices or related sectors. Full time hands-on direct work experience can be in one or more of the following: (Research and development, manufacturing, service; the application of the device technology and its use in health care services and with patients; testing the devices concerned for compliance with relevant national or international standards; conducting performance testing, evaluation studies or clinical trials of the devices.)

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