IVD Medical Devices Expert & Auditor - Netherlands

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????????????IVD Medical Devices Expert & Auditor – Netherlands – 65k EUR

Type; Permanent or Contract

Salary: Negotiable

Location: Netherlands / EMEA / Europe

Travel: Yes, 20%.

Purpose:

The Medical Team is geared towards worldwide certification of medical devices and quality systems.

The role:

An expert in testing and inspection, a company with a real passion for safeguarding quality and safety in the area’s of technology, mobility and environment. With a presence in over fifty countries they are one of the largest players in the industry.

?Your tasks:

• You are responsible for the assessment of technical files and the auditing of the quality system of your customers (from high innovative start-ups to large multinationals, both national and international)


• You act as a linchpin and maintain frequent contact with your customers, colleagues, external experts like physicians, contractors and authorities


• You will have the opportunity to represent the business at conferences


• The position entails travelling within and outside Europe, approximately 20-30% of the time

Your skills:

• Higher vocational or university level education, in life and/or engineering sciences.


• A minimum of 4 years of full time work experiences in medical device related industry, including at least 2 years in R&D, QA/RA.


• Experienced in at least one of the following devices categories and areas of expertise: soft tissue implants, cardiovascular devices, drug device combinations, animal tissue and IVD.


• Experience with quality management systems and relevant laws and regulations, at least CE.


• Project management and auditing experience is considered an advantage certification. We are part of the international assessment

IVD / ANNEX A / ANNEX B / IN VITRO DIAGNOSTICS / BLOOD GROUPING / REAGENTS / ABBOTT / ORGANON / GRIFFOLS / ABO SYSTEMS / RHESUS / ANTI KELL / DUFFY . HIV / BLOOD GROUPS / MOLECULAR BIOLOGY / ANTI DUFFY / ANTI KIDD / ANTIBODIES / CONGENITAL / RUBELLA / TOXOPLASMOSIS / HEREDITARY DISEASE / PHENYLKETUNORIA / HUMAN INFECTIONS / CHLAMYDIA / HLA TISSUE GROUPS / TUMORAL MARKER / TRISOMY / BLOOD SUGAR / CLINICAL CHEMISTRY / HAEMATOLOGY / IMMUNOLOGY / OVULATION / PREGNANCY / SPECIMEN / STERILES / MICROMECHANICS / BIOLOGICAL ACTIVE COATING / NANOMATERIALS . IN VITRO FERTILISATION / MEDICAL DEVICES / TESTING / TECHNICAL / CERTIFICATION / INSPECTION / CRO / CLINICAL TRIALS / CLINICAL RESEARCH / TUV / DEKRA / LRQA / SGS / TUV SUD / TUV NORD / INTERTEK / UL / QA / QUALITY ASSURANCE / 13485 / AUDITING / AUDITORS / REGULATORY AFFAIRS / R&D / MEDICAL DEVICES / RESEARCH / DEVELOPMENT / MANUFACTURING / ENGINEERING / VASCULAR / SOFTWARE / CERTIFICATION / QMS / RESEARCH / PRODUCT DEVELOPMENT / NPD / NPI / MANUFACTURING / HEALTHCARE / CLASS 1 / CLASS 2 / CLASS 3 / CLASS 3A / CLASS 3B / CLASS I / CLASS II / CLASS III / PROCESS ENGINEER / PRODUCTION / NPD / PHARMA / PHARMACEUTICALS / R&D MANAGER / RESEARCH MANAGER / DEVELOPMENT MANAGER / HEAD OF R&D / RESEARCH / DEVELOPMENT / MEDICAL DEVICES / STERILES / SURGICAL / ELECTRO MEDICAL / ELECTRO-MECHANICAL / ORTHOPEADIC / DENTAL / OPHTHALMIC / SOFT TISSUE / VASCULAR / IMPLANTS / IMPLANTABLES / WOUND CARE / WOUNDCARE / CARDIOVASCUALR / MEDICAL DEVICES / EUROPE / UK / UNITED KINGDOM / IVD / MEDICAL DIAGNOSTICS / IN VITRO DIAGNOSTICS / ENGLAND / EUROPE / RELOCATE / US / AMERICA / CALIFORNIA / GERMANY / FRANCE / VALIDATION / ASSAY DEVELOPMENT / BIOCHEMICAL / BIOMEDICAL / MICROBIOLOGY / PRODUCTION / MOLECULAR BIOLOGY / HIV / BLOOD / DIAGNOSTICS / RISK ASSESSMENT / RISK MANAGEMENT / TECHNICAL / UK / LONDON / OXFORDSHIRE / BUCKS / BUCKINGHAMSHIRE / CAMBRIDGE / CAMBRIDGESHIRE / NORTHAMPTON / BIRMINGHAM / WARWICK / WARWICKSHIRE / HERTS / HERTFORDSHIRE / FRANKFURT / LONDON / EUROPE / RELOCATE / BERLIN / PARIS / Amsterdam, rotterDam, Eindhoven, Antwerp, Maastricht, leuven, breda, Alkmaar, Netherlands, Europe, drachten, Leeuwarden, Groningen, assen, leiden / BELGIUM / FRANCE / GERMANY / CERTIFICATION / NOTIFIED BODY / SWEDEN . SWITZERLAND / MEDTRONIC / List A:

— Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups: ABO system, rhesus (C, c, D, E, e) anti-Kell,

— reagents and reagent products, including related calibrators and control materials, for the detection, confirmation and quantification in human specimens of markers of HIV infection (HIV 1 and 2), HTLV I and II, and hepatitis B, C and D.

List B:

— Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups: anti-Duffy and anti-Kidd,

— reagents and reagent products, including related calibrators and control materials, for determining irregular anti-erythrocytic antibodies,

— reagents and reagent products, including related calibrators and control materials, for the detection and quantification in human samples of the following congenital infections: rubella, toxoplasmosis,

— reagents and reagent products, including related calibrators and control materials, for diagnosing the following hereditary disease: phenylketonuria,

— reagents and reagent products, including related calibrators and control materials, for determining the following human infections: cytomegalovirus, chlamydia,

— reagents and reagent products, including related calibrators and control materials, for determining the following HLA tissue groups: DR, A, B,

— reagents and reagent products, including related calibrators and control materials, for determining the following tumoral marker: PSA,

— reagents and reagent products, including related calibrators, control materials and software, designed specifically for evaluating the risk of trisomy 21,

— the following device for self-diagnosis, including its related calibrators and control materials: device for the measurement of blood sugar / Companion Diagnostics / Infectious diseases / Cancer diagnostic or genetic tests