DNV
Location
Dallas, TX | United States
Job description
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.
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:
What We Offer:
**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 ([email protected]). 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.
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:
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:
General Expectations:
What is Preferred
Job tags
Salary