Job Description Summary
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.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 ensure customer satisfaction and efficiency of the business.
Project manage auditing teams, as appropriate, to enhance efficiencies, improve client satisfaction and ensure compliance with standards.
Qualifications
To be considered for this role, you’ll require a minimum of 5 years of professional experience in relevant field of healthcare products or related activities e.g.:
Work in medical devices industry and/or in vitro diagnostic devices(preferred) or closely related industries (e.g., pharmaceutical industry) such as research and development, manufacturing, quality management, regulatory affairs.
Minimum 2 years of relevant professional experience shall be in clinical auditing.
Extensive knowledge of ISO 20916:2019, EU IVDR 2017/746, ISO 14155:2020, EU-MDR 2017/745, 21 CFR Parts 50, 54, 56 and 812
Work experience in positions with significant QA, Regulatory or management systems responsibility.
Medical device experience from auditing/quality
Experience auditing against recognized standards.
Experience of working under own initiative and in planning and prioritizing workloads
University or technical college degree or equivalent qualification in relevant sciences such as: Medicine, Pharmacy, Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Health Technology, Toxicology, Physics, Biophysics, Material Science Biomedical Engineering, Mechanical, Electrical or Electronic Engineering, Computer & Software Technology, Human Physiology, Nursing, Quality Management.
Other
Work remotely
Around 25% travel
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be phenomenal, we do what’s right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We encourage people with the creativity and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Primary Work Location
USA NJ - Franklin LakesAdditional Locations
USA AL - Birmingham - Vestavia, USA AL - Birmingham - Vestavia, USA AZ - Nogales, USA AZ - Nogales RLI, USA AZ - Tempe BPV Building 1, USA AZ - Tempe BPV Building 2, USA AZ - Tempe BPV Building 4, USA AZ - Tempe Headquarters, USA CA – Brea, USA CA - El Cajon, USA CA - Irvine Neomend, USA CA - Irvine SenoRx, USA CA - Milpitas 135, USA CA - Milpitas 155, USA CA - Ontario, Wall Street, USA CA - Redlands Distribution Ctr, USA CA - San Diego (BDB), USA CA - San Diego (IDS), USA CA - San Diego Bldg A&B, USA CA - San Diego - Otay Mesa, USA CA - San Diego - Road to the Cure, USA CA - San Diego TC Bldg C&D, USA CA - San Jose (Reagents), USA CA - San Jose - Montecito, USA CA Temecula {+ 86 more}Work Shift
NA (United States of America)At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.
Salary ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary offered to a successful candidate is based on experience, education, skills, and actual work location. Salary ranges may vary for Field-based and Remote roles.
Salary Range Information
$103,500.00 - $170,800.00
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