QA Auditor - Medical Device (IVD)

BSI Group America Inc   •  

Rochester, NY

Industry: Professional, Scientific & Technical Services

  •  

5 - 7 years

Posted 55 days ago

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

About You

This client-facing role is designed for someone who is highly knowledgeable, passionate about helping companies improve, and committed to continual learning. Please carefully review the qualifications listed below and apply if you meet the criteria.

Qualifications and Education Requirements:

  • Undergraduate degree in engineering, science, or other related field
  • Knowledge of CMDCAS and CE Mark
  • 5-8 years of quality management experience in medical device/healthcare industry
  • 2+ years of “hands on” medical device manufacturing experience in one or more of the following:
    • Research and development, manufacturing, or service
    • 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
    • Performance testing, evaluation studies or clinical trials of the devices.
  • Experience with medical devices within one of the following areas:
    • In-Vitro Diagnostic (IVD)
    • Organic
    • Medical Device Software
  • Ability to travel at least 80% of the time (car and/or plane)

 

Preferred Skills and Experience:

  • Certified ISO/13845 Quality Assurance Auditor highly preferred