Principal QA Systems Specialist - Biomedical/Medical Devices

Posted 29 January by Bosch Global Associates Ltd

Principal QA Systems & Compliance Specialist - IVD/Medical Devices - Netherlands

Type: Permanent.

Salary: Negotiable.

Holiday allowance: Yes.

Purpose:

The Prin. Quality Systems & Compliance Specialist serves as a Quality representative to improve awareness, visibility, and communication on Capital Equipment Installation & Servicing quality initiatives in support of departmental, site, divisional and global quality goals and priorities.

Responsibilities include:

  • Exercises a high degree of autonomy through the development and management of anefficient and effective Installation & Servicing quality system sub process which complies with all current medical devices standards such as 21 CFR Part 820, ISO 13485 and the MDD; ?
  • Provides focused quality systems support for new product introductions and acquisition integrations ; ?
  • Establishes the industry benchmark for Installation & Servicing Quality Systems best practice, determines robust, practical, compliant solutions for the business; ?
  • Leads system improvement teams using a variety of different methodologies and selecting appropriate techniques for problem solving and process improvements; ?
  • Monitors adherence to quality master plan schedules, and elevation to stakeholders and leadership team, as appropriate. ?
  • Monitors system performance though the identification and measurement of key performance indicators. ?

Experience and skills:

  • 7-8 years’ Medical Device experience and preferably experience with capital equipment; ?
  • Comprehensive understanding of the QSR, cGMP and ISO/MDD standards. ?
  • An excellent communicator with the ability to influence others; ?
  • Strong command of the English language (verbal & written); ?
  • Demonstrates a high level of initiative through continuous questioning of current practices; ?

COMPLIANCE / QUALITY MANAGEMENT / MEDICAL DEVICES / QA / QUALITY ASSURANCE / QC / QUALITY CONTROL / ENGINEER / ENGINEERING / CAPA / AUDITOR / AUDITS / AUDITING / SCIENTIST / ASSOCIATE / REPRESENTATIVE / QMS / QUALITY MANAGEMENT SYSTEMS / 13485 / MEDICAL DEVICES / HEALTHCARE / PHARMA / MEDICAL / HOSPITAL / MED TECH / MEDICAL TECHNOLOGY/QMS / QUALITY SYSTEMS / ENGINEER / ENGINEERING / QUALITY MANAGEMENT / REGULATORY COMPLIANCE / MDD / ISO 13485 / ISO 9001 / CAPA / 21 CFR PART 820 / ISO / QA SPECIALIST / SENIOR QA ENGINEER / QA ENGINEER / COMPLIANCE / REGULATORY COMPLIANCE / EQUIPMENT / CAPITAL EQUIPMENT / QA REPRESENTATIVE / EQUIPMENT / VALIDATION / OQ / PQ / NCEP / Amsterdam, rotterdam, Eindhoven, Antwerp, Maastricht, leuven, breda, Alkmaar, Netherlands, Europe, drachten, Arnhem, Leeuwarden, Groningen, assen, leiden, holland, arnhem, nederland, Nijmegen / UK / FRANCE / BELGIUM / SWISS / GERMANY / EUROPE / SWITZERLAND / UNITED KINGDOM / LONDON / MILTON KEYNES / BEDFORDSHIRE / MIDLANDS / OXFORD / OXFORDSHIRE / CAMBRIDGESHIRE / SOUTH WEST / SWINDON / WILTSHIRE / GLOUCESTER / GLOUCESTERSHIRE / BRISTOL / SOMERSET / HAMPSHIRE / SURREY / MIDDLESEX / BERKSHIRE / SE LONDON / KENT / SUSSEX / NORTHAMPTON / NORTHAMPTONSHIRE / EAST ANGLIA / SUFFOLK / NORFOLK / ESSEX / CAMBRISGESHIRE / CAMBRIDGE / PETERBOROUGH / BEDFORD / HERTS/ HERTFORDSHIRE / INTERTEK / UL / BUCKS / BUCKINGHAMSHIRE / HEREFORSHRIE / STAFFORD / STAFFORDSHIRE / CHESHIRE / NOTTINGHAM / NOTTINGHMASHIRE / MANCHESTER / M62 / M1 / M25 / M20 / M5 / M6 / LANCASTER / LANCASHIRE / LEEDS / YORK / YORKSHIRE / ENGLAND / WALES / MILTON KEYNES / BEDFORD / BEDFORDSHIRE / NORTHAMPTON / HAMPSHIRE / BASINGSTOKE / SOUTHAMPTON / BRIGHTON / SOUTH EAST / CAMBRIDGE / CAMBRIDGESHIRE / NORFOLK / NORWICH / SUFFOLK / IPSWICH / HAVERHILL / ROMFORD / MIDDLESEX / SLOUGH / WEST SUSSEX / SURREY / MAIDSTONE / DARTFORD / TONBRIDGE / HYTHE / ASHFORD / BIRMINGHAM / LEICESTER / LEICESTERSHIRE / NOTTINGHAM / NEWCASTLE / YORK / GRIMSBY / LINCOLN / LINCOLNSHIRE / WORCESTER / WORCESTERSHIRE / WARWICK / WARWICKSHIRE / HEREFORD / HEREFORDSHIRE / SOMERSET / BATH

Required skills

  • Medical Devices
  • Quality Management
  • Quality System
  • COMPLIANCE
  • ISO13485

Reference: 29883365

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