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Medical Device Quality Assurance Specialist

1 month ago

Reston, Virginia, United States The British Standards Institution (BSI) Full time
About the Role

This role is to perform as a Medical Device Auditor. The individual will be responsible for delivering BSI's 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.

The candidate must have a minimum of 4 year experience in the medical device field of which 2 years must be hands-on medical device design, manufacturing, or testing experience.

The candidate will develop familiarity with BSI systems and processes as they go through the qualification process.

Essential Responsibilities:
  • Analyze quality systems and assess ISO 13485, CE Marking and MDSAP schemes.
  • Responsible for attending any required training and following all procedures/processes/policies within BSI for management of clients, management of a home based office, use of BSI equipment and communication both internal and external to the organization.
  • The candidate shall achieve qualification to Client Manager status following Qualifying Review
  • Participate in additional training based on future business needs.
  • Responsible for managing a portfolio of assigned clients that are assigned by the planning team based on location and a match of qualifications and client contract requirements.
  • Responsible for contacting clients and scheduling the visits, planning the assessments, making travel plans, conducting the assessments and reporting and managing the results.
  • Responsible for monitoring the client accounts to ensure that records, PointGlobal information, visit cycle, invoicing and other related matters are properly dealt with to assure client satisfaction is maintained.
  • Responsible for acting as a team member.
  • Any other assignments as needed to meet assessment delivery business objectives
About You

This role provides an opportunity for a focused, ethical and ambitious professional to gain visibility within the organization.

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

This position requires a minimum of 100% travel to and from clients. This includes both land (car) and air travel.

Minimum Hands-On Experience

This role is for you if you have a minimum of four years of full-time hands-on work experience in the form of the following areas of expertise:

  • Design and manufacturing of medical devices in specific backgrounds such as:
  • Electromechanical
  • Metallurgical
  • Injection and forged molding
  • Advanced software for class IIb and class III devices

A minimum of degree level qualifications relevant to medical devices and your hands-on work experience (electrical, mechanical or bioengineering / biology or microbiology / chemistry or biochemistry / computer and software technology)

The salary for this position can range from $90,100 to $123,860 annually; actual compensation is based on various factors, including but not limited to, the candidate's competencies, level of experience, education, location, divisional budget and internal peer compensation comparisons.

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.

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.