MDR Assessor/Lead Auditor - Non-Active Orthopaedics & Non-implantable- Remote

Local Unit & Position Description

DNV's Healthcare Division is seeking to fill the role of Medical Device Assessor/Lead Auditor. This position can be remote from anywhere in the Continental U.S.

DNV Healthcare Division is the vanguard of quality improvement in the healthcare industry through promoting adoption and ensuring compliance with internationally recognized ISO 9001 quality management and accreditation standards.

Our teams of highly qualified healthcare professionals work as trusted partners with providers nationwide to ensure the highest quality and safest care. Find out more about how we have been driving improvement in the healthcare industry at the following link: https://www.dnv.com/assurance/healthcare/index.html

Position Qualifications

What Is Required

• Bachelor s Mechanical/Materials engineering / Microbiology, bioengineering; human physiology
• Minimum 4 years in the medical devices related relating to non-active medical devices and devices in sterile condition.
• ISO 13485 Lead Auditor (minimum 1 year auditing experience)
• Knowledge of medical device risk management e.g. ISO 14971
• Have successfully completed training and competence evaluation within Medical Device Directive and ISO 13485
  • Include Audit Logs.
• Current valid driver's license
• We conduct a pre-employment background check and drug screening.

Minimum competencies:

• Non-Active osteo- and orthopaedic Implants
• Non-active non-implantable orthopaedic and rehabilitation devices
• Non-Active soft tissue and other functional implants
• Non-active non-implantable diagnostic devices
• Non-active non-implantable instruments
• Non-Active soft tissue and other implants
• General non-active non-implantable devices used in healthcare and other non-active non-implantable devices

What is Preferred

• Experience/qualification with sterilization highly desired (codes MDS 1005.1-1005.5)

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 on the basis of 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.

For more information about your rights under the law, see:

https://www.eeoc.gov/know-your-rights-workplace-discrimination-illegal-poster

Read more here:

Diversity at DNV

Meet our Employees

About DNV

Careers in DNV

As required by the Colorado Equal Pay Transparency Act and New York City Salary Transparency Law, DNV provides a reasonable range of compensation for roles that may be hired in Colorado or New York City. 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 and New York City, NY only, the range of starting pay for this role is $130000- $180000.

Company & Business Area Description

DNV is the independent expert in assurance and risk management, operating in more than 100 countries. Through our broad experience and deep expertise we advance safety and sustainable performance, set industry benchmarks, and inspire and invent solutions.

We are one of the world s leading certification, assurance and risk management providers. Whether certifying a company s management system or products, providing training, or assessing supply chains, and digital assets, we enable customers and stakeholders to make critical decisions with confidence. We are committed to support our customers to transition and realize their long-term strategic goals sustainably, and collectively contributing to the UN Sustainable Development Goals.

Equal Opportunity Statement

DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity!

Responsibilities


Equal Opportunity Employer
Equal Opportunity Employer: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin.

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