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

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.

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.

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).

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.

What we offer

What We Offer

Generous Paid Time Off (Vacation, Company Holidays, Parental Leave, Sick, and Disability). Multiple Medical, Dental, and Vision Benefit Plans to choose from. Spending Accounts - FSA, Dependent Care, Commuter Benefits, Company-Seeded HSA. 401(K) with company match.Company provided life insurance, short-term, and long-term disability benefits.Education reimbursement program. Employer-Paid, therapist-led, virtual care services through Talkspace. Flexible work schedule with hybrid/remote opportunities.Benefits may vary based on position, tenure, location, and employee election

How We Do It

We Care, We Dare, We Share

DNV is a proud equal opportunity employer committed to building an inclusive and diverse workforce. All employment is decided based on qualifications, merit, or business need, without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

DNV is committed to ensuring equal employment opportunity, including providing reasonable accommodations to individuals with a disability. US applicants with a physical or mental disability who require a reasonable accommodation for any part of the application or hiring process may contact the North America Recruitment department (hrrecruitment.northamerica@dnv.com). Information received relating to accommodations will be addressed confidentially.

DNV is proud to announce being named one of Houston's best places to work in the 2022 Houston Business Journal - Best Places to Work competition.

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Diversity at DNV

Meet our Employees

About DNV

Careers in DNV

As required by the Pay Transparency laws in Colorado, New York City, California, and Washington, DNV provides a reasonable range of compensation for roles that may be hired in those locations. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location. For the state of Colorado, New York City, NY, California, and Washington only, the range of starting pay for this role is $90,000 - $170,000.

About You

What Is Required What Makes a Successful Candidate

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 BioengineeringMechanical EngineeringMetallurgyElectrical or Electronics EngineeringPolymer or Chemical EngineeringComputer Science or EngineeringBiology or MicrobiologyPhysiologyChemistryPhysicsDentistry, 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 instrumentsDevices 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 careNon-active dental devices and accessoriesDevices for radiation therapy and thermo- therapyMedical devices utilizing tissues of animal origin.Medical devices incorporating derivatives of human blood.

General Expectations

Excellent working knowledge of medical device management systems, medical device compliance and auditing techniques.Sound knowledge of regulatory requirements (e. g., MDR (EU 2017/745)), and other related requirements.Auditor training and experience according to ISO 13485, MDR (EU 2017/745), and MDSAP a plus.Strong knowledge of medical devices and product technologies.Experience auditing against recognized standards.Excellent working knowledge of medical device management systems, medical devices legislation, and medical device standards (harmonized, national and international), common specifications and guidance documents.Experience with medical device standards for active and non-active medical devices.Experience with Risk Management (EN ISO 14971).Pro-active attitude and excellent organizational skills and the ability to work independently as well as within project teams. Excellent interpersonal, verbal, written and presentation skills.Current valid drivers licenseDomestic and/or international travel required, estimated to be up to 60%.We conduct a pre-employment background check and drug screen.

What Is Preferred

Previous experience as an Auditor with a Notified Body or Conformity Assessment Body advantageous but not required.