Ivdr Assessor

Job Category Auditor As part of our continued growth we are looking to recruit technical and experienced In-Vitro Diagnostic Medical Device Assessors and Lead Auditors The successful candidates will be responsible for planning and conducting audits assessments against the manufacturing of medical devices in accordance with ISO 13485 IVDR 2017 746 and MDSAP standards enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards Key Accountabilities Assessor 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 communication Conduct Technical File reviews specific for products being authorized Complete all chargeable work within the required timeframes to ensure customer satisfaction and efficiency of the business Complete specific 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 decisions within target timescales and in line with DNV policies and accreditation approval requirements Key Accountabilities Auditor 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 Conduct surveillance audits including follow-up activities in accordance with established procedures maintaining a high standard of service delivery that ensures effective customer relationships Complete all chargeable work within the required timeframes to ensure customer satisfaction and efficiency of the business 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 Project manage auditing teams as appropriate to maximize efficiencies enhance client satisfaction and ensure compliance with standards Responsibilities Flexible work arrangements for better work-life balance Generous Paid Leaves Annual Sick Compassionate Local Public Marriage Maternity Paternity Medical leave Medical benefits Insurance and Annual Health Check-up Pension and Insurance Policies Group Term Life Insurance Group Personal Accident Insurance Travel Insurance Training and Development Assistance Training Sponsorship On-The-Job Training Training Programme Additional Benefits Long Service Awards Mobile Phone Reimbursement Company bonus Profit share Benefits may vary based on position tenure contract grade level 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 Qualifications Assessors and Auditors shall have a technical college degree in a relevant product or medical area as described below In-Vitro Diagnostic devices Biology or Microbiology Chemistry or Biochemistry Human Physiology Medical Technology or Biotechnology Medicine Veterinary Medicine Biomedical science - e g haematology virology molecular diagnostics Nursing Pharmacy Pharmacology Toxicology Physiology In addition to a relevant educational degree candidates must have a minimum 4 years work experience full time in an In-Vitro diagnostic medical device related industry academia or hospital environment with at least 2 of these years in the design manufacturing testing or use of the device in which they are qualified to Audit or Assessment and or experience as an assessor or auditor in a notified body Specifically Auditor - Practical experience in the quality management system and specific production process technologies for the IVD medical devices Assessor - Practical experience in conducting and or assessing performance evaluation data or related scientific aspects with in-vitro diagnostic medical devices in one or more of the following areas Microbiology Immunology Genetic testing Cancer Biology and Molecular Biology A PhD in a relevant area for in-vitro diagnostic medical devices can substitute 3 years of work experience provided it includes 2 years experience in design manufacture or testing In addition to the above knowledge of the following would be preferred 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 Experience with Harmonized medical device standards for In-Vitro diagnostic medical devices Experience with Risk Management EN ISO 14971 Medical device experience from auditing work Experience auditing against recognized standards Experience of working under own initiative and in planning and prioritizing workloads Should have a flair for technical writing essential for exhaustive report writing About Us About SCPA We help our customers respond to the increased demand for trust and transparency around products assets supply chains and ecosystems driving the transformation of the assurance industry Whether certifying products sharing claims or optimizing and decarbonizing supply chains DNV helps companies manage risks and realize their long-term strategic goals improving ESG performance and generating lasting sustainable results Drawing on our wide technical and industry expertise we work with companies worldwide to bridge trust gaps among consumers producers and suppliers