Great that you're thinking about a career with BSI!

About the role

BSI is hiring a Quality Assurance (QA) Auditor – Medical Devices to join our Operations Delivery team. This role is remote with frequent domestic travel to client sites.  

Our QA Auditors (known internally as Client Managers) are the MVPs of the Assurance 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 experience working with medical devices in the following categories: IVD, Organic or Medical Device Software. They travel from client to client, utilizing their knowledge and expertise while continually learning on the job – getting better at their craft every day. This position involves extensive travel (nearly 100%), which means it is ideal for people who do not have ongoing weeknight commitments or obligations that will not allow them to spend several nights a week away from home. 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.

Essential 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, only candidates with degrees in biology, microbiology, chemistry, biochemistry, computer and software technology, electrical/electronic/mechanical or bioengineering, human physiology, medicine, pharmacy, 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, audit or research), including at least two years in the area of quality management.  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.

We seek someone who meets all of the following criteria:

• Can deliver and strive for superior performance, and who can achieve challenging objectives
• Are proactive with people and can lead by example
• Can demonstrate passion for the business and can inspire others
• Have integrity, ensuring that business is conducted in an ethical manner
• Have commercial focus, understanding customers’ needs and adding value

Travel: 

• This position requires a minimum of 85% travel to and from clients.  This includes both land (car) and air travel.

Languages:

• English as a minimum.

Physical Demands:

• The physical demands of this role are primarily associated with travel and the carrying/lifting of luggage

About BSI

Our ambition is to be recognized and valued globally as a best-in-class company; a client-driven, efficiently-run, growing business. BSI has come a long way since being founded in 1901. Today, we are a global business services organization, respected world over for the development of standards; assessment of management systems; testing and certification of products and services; providing software solutions; and the delivery of training courses. We offer diverse career paths from auditing to sales, product development to finance, and from IT to marketing.

With over 4,000 employees in more than 172 countries it means that career opportunities are vast. BSI challenges mediocrity and complacency to help embed excellence into the way people and products work. That means showing businesses how to improve performance, reduce risk and achieve sustainable growth.

Our Vision: “Making excellence a habit”, it describes our way forward and our aspiration each day.
Our Mission: “To help organizations embed excellence”, and states our shared purpose.
Our Values: “Integrity – Continual improvement – Inclusivity”, guide us in the way we work and help us deliver our Vision and Mission.

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.

BSI is an Equal Opportunity Employer and we are committed to diversity.

Our Excellence Behaviours: Customer Focus, Accountability, Respect, Communication, Achievement & Leading and Managing others