Sr. Clinical Quality Auditor (Remote)

Job Description SummaryWe have an excellent new opportunity for a Medical Device Lead Auditor to join our global organization. The successful candidate will be responsible for planning, conducting and leading clinical audits for in vitro diagnostic medical devices and in vivo medical devices, in accordance with 21 CFR Parts 50, 54, 56, 812, ISO14155, ISO 20916, EU-MDR 2017/745 and EU-IVDR 2017/746 regulations and standards, enabling the delivery of assessments that meet customer requirements and appropriate standards.

Job Description

We are the makers of possible 

 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

We have an excellent new opportunity for a Medical Device Lead Auditor to join our global organization. The successful candidate will be responsible for planning, conducting and leading clinical audits for in vitro diagnostic medical devices and in vivo medical devices, in accordance with 21 CFR Parts 50, 54, 56, 812, ISO14155, ISO 20916, EU-MDR 2017/745 and EU-IVDR 2017/746 regulations and standards, enabling the delivery of assessments that meet customer requirements and appropriate standards.

• Plan, conduct, and lead complex clinical study audits (Sponsor, Investigator Sites and Clinical Suppliers) (either remote or on site) in accordance with all applicable regulations, standards, mentorship, and the established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.

• Complete audits to assess accuracy and quality of scientific data submitted to the regulatory agencies in support of in vivo medical devices and in vitro diagnostic devices' application.

• Manage audit observations and audit reports through the internal audit database and CAPA process.

• Work with the business units/auditees to develop appropriate actions, provide recommendations, and ensure that the corrections/corrective actions are appropriate and effective.

• Coordinate timely closure of actions.

• Escalate issues to management and/or the business unit, if needed.

• Complete all chargeable work within the required budget and timeframes to …