Senior QA Manager - Medical Devices - Netherlands
Manages the Quality organization and functions at the European Distribution Centre. Responsible for implementing continuous improvements and provides vision and leadership for strategic projects and maintaining the Quality System, including Quality Assurance mandates. Identifies and assures optimal product and process quality within the quality system and regulatory requirements. Understands and applies quality principles to support an effective overall quality system, including initiatives in conjunction with the Director Quality Assurance.
Manages all personnel, activities, initiatives and site specific programs in the achievement of quality organizational goals, as well as Corporate driven initiatives related to the Quality System.
Quality Compliance: Ensures the Quality System is substantially compliant to GMP/QSR practices and standards as defined by the FDA, ISO and regulatory bodies in close coordination with the Quality Systems Manager;
Quality Metrics & Communications: Develops and generates quality metrics reporting/tools as well as process improvements. Responsible for trending/analysis of any Quality data and develops/ maintains SOPs for recording, evaluation and reporting of Quality and reliability data.
Manages all personnel, activities, initiatives and site specific programs in the achievement of quality organizational goals, as well as Corporate initiatives related to the Quality System; ?
Interfaces with other members of Management with respect to regulatory compliance, as well as implementing continuous improvements initiatives; ?
Sets policy and procedures for the Quality processes at the European DC; ?
Responsible for interacting with internal sites and external customers on Quality related issues; ?
Provides vision and leadership for strategic projects; ?
Works collaboratively across functions, regions and business ?units to deliver results; ?
Contributes to organizational efficiencies through ?recommendations regarding new corporate standards and ?procedures; ?
Acts as Subject Matter Expert in internal and external audits.
Ensures the Quality System is substantially compliant to GMP/QSR practices and standards as defined by the FDA, ISO and regulatory bodies in close coordination with the Quality Systems Manager; ?
Develops and generates quality metrics reporting/tools as well as process improvements. ?
Experience and skills:
- B.S. Degree with minimum of 9 years’ experience in quality for medical devices and/or pharmaceuticals. ?
- Comprehensive understanding of the QSR, cGMP and ISO/MDD standards. ?
- Excellent communication skills with the ability to influence others. ?
- High level of initiative & autonomy through continuous questioning of current practices. ?
- Strong command of the English language (verbal & written).
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 / GMP / ISO 13485 / ISO 9001 / CAPA / 21 CFR PART 820 / ISO / QA SPECIALIST / SENIOR QA ENGINEER / QA ENGINEER / COMPLIANCE / REGULATORY COMPLIANCE / MANAGER / QA MANAGER / MANAGERIAL / 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
- Medical Devices
- Quality Management