Great that you're thinking about a career with BSI!
About the role:
Our QA Auditors (known internally as Client Managers) are the MVPs of the Regulatory business. Utilizing their past experience in engineering, design, or quality control of medical devices, combined with rigorous BSI training, they conduct audits 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: IVD, active implantable, vitals monitoring, etc. The QA Auditor travels from client to client, utilizing their knowledge and expertise while continually learning on the job – getting better at their craft every day.
If you enjoy building relationships with customers, exploring new places, and delving deeper into the inner workings of companies, then this could be a very exciting job opportunity for you.
The QA Auditor position is a full-time salaried role with a comprehensive benefits package.
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
- Due to strict regulatory requirements, only candidates with degrees in computer 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 work experience in the field of medical devices or related sectors (e.g. medical industry, healthcare, automotive, aerospace or research), 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.)
At least two 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.
Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.
BSI is an Equal Opportunity Employer and we are committed to diversity.
To protect our candidates and BSI employees during the Covid-19 outbreak, all interviews will take place remotely.