Medical Devices-Assessor/ Auditor

Overview

Assess and audit medical devices per ISO 13485, EU MDR, MDSAP standards.

Key Responsibilities

• performance testing
• compliance testing
• documentation review
• technical review
• audits
• project management

Tasks

-conducting performance testing, evaluation studies or clinical trials of devices. -testing devices for compliance with the relevant national or international standards. -Review of technical documentation -work in the application of device technology and its use in health care services and with patients. -Complete specific projects in relation to medical device procedures, processes, systems and documentation. -Conduct audits (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. -Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business. -If required, undertake reviews of packs and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements. -Work actively with a Team of Assessors/ Auditors. -Conduct Technical File reviews specific for products being authorized. -Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards. -work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies.

Requirements

• iso 13485
• mdr
• iso 14971
• irca auditor
• 5+ years
• qa

What You Bring

-Experience working with Various Digital Tools. -Experience auditing against recognized standards -Solid knowledge of sterilization processes -Experience of working under own initiative and in planning and prioritizing workloads -Experience with scientific literature searches or peer review in the medical context. -Excellent organizational and professional communication skills. -Experience of reviewing audit packs -Good knowledge of ISO 13485, MDD 93/42/EEC/ Indian Medical Device Regulations and their application -University or technical college degree or equivalent qualification in relevant sciences such as: Medicine, Pharmacy, Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Health Technology, Toxicology, Physics, Biophysics, Material Science Biomedical Engineering, Computer & Software Technology, Engineering, Nursing, Quality Management. -Solid knowledge of non-active devices -Work experience in positions with significant QA, Regulatory or management systems responsibility -Qualified MDR Assessor from a reputed EU Notified Body, desirable. -Experience with Harmonized medical device standards and for active & non active devices. -Knowledge of MDR 2017/745, MDSAP, IMDR -Experience with Risk Management EN ISO 14971 -Fluent in written and spoken English. -Registered IRCA lead auditor, or equivalent registration under other recognized body -An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques -5 + years relevant professional experience in quality management is essential.

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Benefits

-Generous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave) -Company bonus/Profit share. -Medical benefits ( Insurance and Annual Health Check-up) -Additional Benefits (Long Service Awards, Mobile Phone Reimbursement) -Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance) -Flexible work arrangements for better work-life balance -Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme)

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

Security Clearance

-background checks will be conducted on all final candidates as part of the offer process, in accordance with applicable country-specific laws and practices.