Medical Device Assessor Ophthalmic
Job Location:
Monthly Salary:
Posted on:
Vacancies:
Job Summary
As part of our continued growth we are looking to recruit technical and experienced Medical Device Assessors/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 2017/745 and MDSAPstandards enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards.
Scope
A Medical Device Auditor evaluates whether medical device companies comply with regulatory requirements and quality standards.
- Auditing Quality Management Systems (mainly ISO 13485).
- Checking compliance with regulations (e.g. EU MDR FDA 21 CFR 820 MDSAP).
- Assessing technical documentation validation and product safety evidence.
- Reporting nonconformities recommending corrective actions and ensuring followup.
- Work collaboratively with crossfunctional and customerfacing teams to ensure audit outcomes strengthen relationships and build confidence.
- Communicate findings clearly and professionally to enhance credibility and reinforce the organizations quality promise to customers.
- Coordinates effectively with crossfunctional stakeholders to ensure timely delivery of outcomes while maintaining the highest levels of customer satisfaction.
- Ensures accurate errorfree audit report submission and collaborates with GCU for timely review and approval.
- Supports the sales team with technical insights qualityrelated inputs and customerfocused information to strengthen proposals enhance customer confidence and drive successful deal closures.
- Maintains required auditor credentials/qualifications and proactively pursues continuous advancement of relevant certifications to support highquality audits and customer success.
Key Accountabilities: Assessor/Auditor
- 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 MDR 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.
- Responsible for carrying 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 MDR 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.
Primary responsibilities
- KPI
- Compliance & Audit Effectiveness
- Error free report
- Customer Satisfaction
- Sales Growth
- Professional credentials & Capability Building
Key behaviors
- Customer-Centricity
- Collaboration & Stakeholder Management
- Clear Credible Communication
- Regulatory & Objectivity
- Mutual respect & Trust
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
Position Qualifications: Assessor/Auditor
- Assessors and Auditors shall have a technical college degree or post graduation in a relevant stream.
- In addition to relevant educational qualifications candidates must have 10 years of professional experience in the medical device industry preferably in ophthalmic products orthopedic implants or devices of animal origin with at least 4 years in the design manufacturing testing or use of such devices.
- Qualified MDR Assessor from a reputed EU Notified Body desirable
- Specifically:
- Practical experience in the quality management system and specific production process/technologies for the medical devices.
- Practical experience in conducting and/or assessing performance evaluation dataor related scientific aspectswith medical devices.
Subject Knowledge on the below would be highly 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 standards for 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 Company
Driven by our purpose of safeguarding life, property and the environment, DNV enables organizations to advance the safety and sustainability of their business.
