IVDR Experienced Auditor

Overview

Perform audits of IVD manufacturers' QMS, ensure IVDR compliance, and manage related projects.

Key Responsibilities

• audit execution
• surveillance audits
• project management
• qms audits
• ivdr documentation
• file review

Tasks

-Complete all chargeable work within the required timeframes to ensure customer satisfaction and efficiency of the business. -Conduct surveillance audits including follow-up activities in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships. -Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards. -Responsible to carry out audits of the manufacturer's quality management system (QMS) and of its suppliers and/or subcontractors when appropriate and to draw up records and reports on the corresponding audits. -Complete projects in relation to IVDR procedures, processes, systems and documentation as requested by the Operations Manager. -If required, undertake reviews of files and make certification recommendations within target timescales and in line with DNV policies and accreditation/approval requirements.

Requirements

• chemistry
• biochemistry
• pharmacy
• technical writing
• auditing
• iso 14971

What You Bring

-Chemistry or Biochemistry -Experience of working under own initiative and in planning and prioritizing workloads. -We conduct a pre-employment background check and drug screen. -Pharmacy, Pharmacology, Toxicology -Experience with Harmonized medical device standards for In-Vitro diagnostic medical devices. -Should have a flair for technical writing, essential for exhaustive report writing. -Experience auditing against recognized standards. -An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques. -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. -Medicine, Veterinary Medicine -Medical Technology or Biotechnology -Biomedical science - e.g. hematology, virology, molecular diagnostics

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Benefits

-Spending accounts – FSA, Dependent Care, Commuter Benefits, company-seeded HSA -Charitable Matched Giving and Volunteer Rewards through our Impact Program -401(k) with company match -Flexible work schedule with hybrid/remote opportunities -Volunteer time off (VTO) paid by the company -Career advancement opportunities -Company provided life insurance, short-term, and long-term disability benefits -Education reimbursement program -Multiple Medical and Dental benefit plans to choose from, Vision benefits -Generous paid time off (vacation, sick days, company holidays, personal days) -Employer-paid, therapist-led, virtual care services through Talkspace

About Dnv

-With over a century of expertise, the company delivers solutions across sectors like Energy, Marine, and Renewables. -Notably involved in high-profile projects like wind farms, maritime safety, and digital transformation in industries. -The company is renowned for setting the highest standards in risk management and developing technology solutions for sustainability. -Its innovations span the digitalization of energy grids to advancing marine safety standards, driving industries forward. -Headquartered in Norway, the company has evolved from a maritime classification society into a multi-sector advisory giant.

Sector Specialisms

Visa Sponsorship

-immigration-related employment benefits, such as visa sponsorship, are not available for this position.

Security Clearance

-pre-employment background check and drug screen will be conducted.