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IVDR Assessor

IVDR Assessor

ConfidentialHyderabad / Secunderabad, Telangana, India
5 days ago
Job description

About Us

We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence.

As a trusted voice for many of the world's most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations.

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.

About The Role

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.

    • What we offer

  • 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.

    About You

    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

    • Education

    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.

    • Skills Required

    Iso 13485, Technical Writing

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    Assessor • Hyderabad / Secunderabad, Telangana, India