Auditor / Lead Auditor - ISO 13485, MDSAP, MDR 2017/745

at  DNV

ABOUT US

We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence.
As a trusted voice for many of the world s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations.

JOB SUMMARY:

Individuals in this role must have successfully completed a university or technical college degree in the following or similar degree fields: Biomedical Engineering, Biomechanical Engineering, Mechanical Engineering, Metallurgy, Electrical / Electronics Engineering, Chemical Engineering, Polymer Engineering, Computer Science / Engineering, Biology, Microbiology, Physiology, Chemistry, Physics, Dentistry, Medicine, Pharmacy, or Medical Technology.
This role requires 4-years of professional experience working in the medical device industry, in the field of healthcare products or related activities. Professional experience must include at least 2-years in the manufacturing, auditing or research and quality management.
The successful candidate possesses knowledge and understanding covering a wide range of medical device or healthcare technologies and/or products with direct experience in the design, research, development, manufacturing, processing, testing, servicing, installation, maintenance, auditing, conducting of clinical trials of medical devices, or work in carrying out inspections, clinical evaluations and experimental and/or clinical research.
Individuals in this role will audit medical device manufacturers Quality Management System(s) to verify conformity with the European Medical Device Regulation (MDR EU 2017/745), Medical Device Single Audit Program (USA, Canada, Brazil, Japan, Australia) and international quality system standards (e.g., ISO 13485).

EDUCATION:

Auditors shall have a university or technical college degree in a relevant product or medical area, as described below:

• Biomedical Engineering, Biomechanical Engineering or Bioengineering
• Mechanical Engineering
• Metallurgy
• Electrical or Electronics Engineering
• Polymer or Chemical Engineering
• Computer Science or Engineering
• Biology or Microbiology
• Physiology
• Chemistry
• Physics
• Dentistry, Medicine, or Pharmacy

EXPERIENCE:

In addition to a relevant educational degree, candidates must have a minimum of 4-years work experience (full time) in a medical device or healthcare products related industry, with at least 2 of these years in manufacturing, auditing or research and quality management.

Experience with medical devices or healthcare products falling within two or more of the following categories desired:

• Active non-implantable devices for imaging, monitoring and/or diagnosis.
• Active non-implantable therapeutic devices and general active non-implantable devices.
• Non-active implants and long term surgically invasive devices.
• Non-active non-implantable devices.
• Medical devices incorporating medicinal substances.
• Reusable surgical instruments
• Devices incorporating software / utilizing software / controlled by software, including devices intended for controlling, monitoring, or directly influencing the performance of active or active implantable devices.
• Devices with a measurement function.
• Devices for wound care
• Non-active dental devices and accessories
• Devices for radiation therapy and thermo- therapy
• Medical devices utilizing tissues of animal origin.
• Medical devices incorporating derivatives of human blood.

ABOUT THE ROLE

DNV Supply Chain and Product Assurance has immediate openings on our growing Medical Device Team!
DNV Supply Chain and Product Assurance is looking to recruit technical and experienced personnel to be Medical Device Auditors and Lead Auditors throughout North America. This position can be remote from anywhere in the Continental U.S.A.
The successful candidate(s) will be responsible for conducting audits of medical device manufacturers, in accordance with ISO 13485, MDSAP, and the Medical Device Regulation (EU 2017/745), enabling the delivery of certification services that meet customer requirements and appropriate accreditation standards.

WHAT YOU’LL DO:

• Audit manufacturers ensuring continued compliance to regulatory requirements, in accordance with ISO 13485, MDSAP, and the Medical Device Regulation (EU 2017/745).
• Utilize knowledge of regulatory requirements and apply to manufacturers processes, management systems, and products.
• Perform audits in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.
• Document and report audit activities and results utilizing analytical skills, technical knowledge, and excellent written communication skills.
• Provide timely and accurate reviews of customer corrective actions.
• Analyze complex regulatory requirements and make sound determinations of the proper course of action.
• Work with minimal supervision with the ability to assess compliance to regulatory requirements.
• Work independently or within a team environment utilizing positive interactive skills.
• Maintain appropriate auditor credentials and pursue advancement of those credentials and other related credentials as needed.
• Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business.