Job Description
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 13485, IVDR 2017/745 and MDSAP standards, 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 follow‑up.
- Work collaboratively with cross‑functional and customer‑facing teams to ensure audit outcomes strengthen relationships and build confidence.
- Communicate findings clearly and professionally to enhance credibility and reinforce the organization’s quality promise to customers.
- Coordinates effectively with cross‑functional stakeholders to ensure timely delivery of outcomes while maintaining the highest levels of customer satisfaction.
- Ensures accurate, error‑free audit report submission and collaborates with GCU for timely review and approval.
- Supports the sales team with technical insights, quality‑related inputs, and customer‑focused 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 high‑quality audits and customer success.
Key Accountabilities: Assessor/Auditor
- 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 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 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 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
- 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.
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 data or related scientific aspects with 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.
Security and compliance with statutory requirements in the countries in which we operate is essential for DNV. Background checks will be conducted on all final candidates as part of the offer process, in accordance with applicable country-specific laws and practices.
About Life Sciences
We help our customers in medical devices, healthcare, and aquaculture/ocean industries build trust and transparency across their products, assets, and supply chains. By working with customers to certify medical technologies, support safe and sustainable healthcare practices, and advance responsible aquaculture and ocean stewardship, we help manage risks, meet regulatory demands, and achieve long-term goals. Drawing on deep technical expertise, we partner with customers worldwide to bridge trust gaps between patients, providers, producers, and consumers—driving sustainable results and improved ESG performance.
