IVDR Assessor
IVDR Assessor
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Job Description
As part of our continued growth we are looking to recruit technical and experienced In-Vitro Diagnostic Medical Device Assessorsand Lead Auditors. The successful candidates will be responsible for planning and conducting audits / assessments against the manufacturing of medical devices in accordance with ISO 13485IVDR 2017/746 and MDSAPstandards 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 clients 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 manufacturers 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*
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 yearswork 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 dataor related scientific aspectswith 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 substitute3 years of work experienceprovided it includes 2 years experienceindesign 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.
Employment Type
Full-Time
