MDR Assessor/Lead Auditor - Non-Active Dental Devices & Materials- Remote
Company: DNV
Location: Medford
Posted on: May 24, 2023
Job Description:
Local Unit & Position DescriptionDNV'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.htmlPosition
QualificationsWhat 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 dental implants
- Non-Active dental materials
- Non-Active neurovascular implants
- Non-Active soft tissue and other functional implants
- Non-Active soft tissue and other implants
- Genreal non-active non-implantable devices used in healthcare
and--other non-active implantable devicesWhat 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 ItWe Care, We Dare, We
ShareDNV 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-posterRead
more here:Diversity at DNV Meet our EmployeesAbout DNVCareers in
DNVAs 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
$90000 - $180000Company & Business Area DescriptionDNV 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 StatementDNV 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!
Keywords: DNV, Medford , MDR Assessor/Lead Auditor - Non-Active Dental Devices & Materials- Remote, Accounting, Auditing , Medford, Massachusetts
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