Medical Device Auditor

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

• Seniority: Mid Level
• Education: Bachelor's degree required
• Languages: English