IVDR Assessor/Auditor

DNV; Madrid; Presencial; EUR 45.000 - 70.000; Jornada completa

Descripción de la vacante

A leading certification body in Spain seeks experienced In-Vitro Diagnostic Medical Device Assessors and Lead Auditors to conduct audits and assessments in accordance with relevant standards. Ideal candidates will have a technical college degree in a relevant medical area and at least 4 years of experience in the diagnostics industry. Responsibilities include conducting assessments, auditing QMS, and managing projects to ensure compliance with ISO standards. This role offers a supportive work environment and opportunities for professional growth.

Servicios

Competitive salary and benefits package

Opportunities for professional growth

Supportive team environment

Social benefits per local conditions

Formación

• Minimum 4 years’ work experience in an In-Vitro diagnostic medical device-related industry.
• At least 2 years in design, manufacturing, testing, or use of the device.
• Experience as an assessor or auditor in notified body.

Responsabilidades

• Conduct assessments on client sites or desk-based, maintaining service quality.
• Manage audits of the manufacturer's quality management system and suppliers.
• Complete specific projects and reviews related to IVDR procedures.

Conocimientos

Technical background in medical device assessment

Knowledge of ISO 13485

Experience in auditing

Report writing skills

Communication skills

Educación

Technical college degree in relevant medical field

PhD in relevant area (substitutes work experience)

Descripción del empleo

As part of our continued growth, we are looking to recruit technical and experienced In-Vitro Diagnostic Medical Device Assessors and 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 2017/746 and MDSAP standards, 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 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 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.
• Conduct Technical File reviews specific for products being authorized.

Key Accountabilities: Auditor

• Responsible to carry 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 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.

Our working culture is based on respect for one another and the appreciation of work-life balance.

• A competitive salary and benefits package
• A stimulating and diverse work environment with opportunities for professional growth and development – learn from highly skilled colleagues and customers
• A supportive and friendly team of experts and innovators
• Social benefits as per DNV location (local conditions apply)

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 in a relevant product or medical area, as described below.

In-Vitro Diagnostic devices

• Biology or Microbiology
• Genetic testing
• Oncology
• Chemistry or Biochemistry
• Human Physiology
• Medical Technology or Biotechnology
• Medicine, Veterinary Medicine
• Biomedical science - . haematology, virology, molecular diagnostics
• Nursing
• Pharmacy, Pharmacology, Toxicology
• Physiology

In addition to a relevant educational degree, candidates must have a minimum 4 years’ work 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, as well as 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 data or related scientific aspects with 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 substitute 3 years of work experience provided it includes 2 years’ experience in design, 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.

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.