Technical Assessor & Lead Auditor - Active Devices - Remote

Local Unit & Position Description

DNV - Product Assurance is an accredited Certification Body and MDR approved Notified Body for Medical Devices. We provide global market access by testing and certifying the safety and quality of products and systems to international safety and quality standards and regulations. Our high professional standards and our sustainable approach guarantee you a forward-thinking work environment, within an organisation that invests in its employees, and is committed to providing you with continued development.

We are looking to recruit technical and experienced Active Medical Device Assessors and Lead Auditors throughout North America. The successful candidates will be responsible for planning and conducting audits / assessments against the manufacturing of medical devices, in accordance with ISO 13485, MDD 93/42/EEC, MDR 745/2017 and MDSAP standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards.

This position can be remote from anywhere in the Continental U.S.

What You ll Do

• Interact directly with customers at all levels of management in developing timely, complete and accurate reports of their current level of compliance or implementation of their management system
• Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards.
• Document and report audit activities and results
• Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business.
• Schedule and plan audit activity with customers
• Maintains appropriate audit credentials and pursues advancement of those credentials and other related credentials as needed.
• On- and off-site quality system assessments of Medical Devices against Medical Device Regulation
• Conduct Technical File reviews specific for products being authorized.
• Conduct assessments (either desk-based or on client s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.
• Perform 3rd party onsite ISO 13485 (Medical Device) audits for North America customers
• Provide timely and accurate reviews of customer corrective action and closure

Position Qualifications

What is Required

• Practical experience in conducting pre-clinical testing or assessing preclinical data with medical devices in one or more of the following areas such as biological safety, physical, chemical and microbiological characterization, stability, shelf life, performance and safety
• Technical college degree in a relevant product or medical area such in Computer and Software Technology, Electrical, Electronic, Mechanical or Bioengineering or Medical Technology
• Must have a minimum 4 years work experience (full time) in a medical device related industry, with at least 2 of these years in the design, manufacturing, testing or use of the device in which they are qualified to Audit / Assess, and/or experience as an assessor in a notified body (full five technical documentation assessments).
• Must be willing and able to travel up to 80% of the time
• A PhD in a relevant area for medical devices can substitute 3 years of work experience provided it includes 2 years experience in design, manufacture or testing.
• We conduct a pre-employment background check and drug screen.
• Must have a valid Drivers License

To be considered for this role, you will have professional experience in a relevant field of healthcare products or related activities, for example:

• Work in the application of device technology and its use in health care services and with patients
• Work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies
• Programming (Software) experience would be beneficial
• Testing devices for compliance in accordance to the relevant national or international standards
• Conducting performance testing, evaluation studies or clinical trials of devices
• Work in medical devices industry or closely related industries (e.g. pharmaceutical industry) in a research and development, manufacturing, quality management or regulatory affairs capacity

In addition to the above you ll also need to demonstrate the following;

• An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques
• Experience with Sterilization techniques (such as ETO, Gamma, Steam, Dry Heat) and formal qualification desirable
• Work experience in positions with significant QA Regulatory or management systems responsibility
• Medical device experience from auditing/work
• Experience with Risk Management EN ISO 14971
• Experience with Harmonized medical device standards for active & non active medical devices
• Experience auditing against recognize standards

Experience with Active Devices may include: (Must have one or more)

• Other active non-implantable devices for monitoring and/or diagnosis
• 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
• Standalone software
• Active non-implantable imaging devices utilizing ionizing radiation
• Active non-implantable imaging devices utilizing non-ionizing radiation
• Active non-implantable device for monitoring of vital physiological parameters

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 ([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.

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

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

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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 $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!

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