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
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.
