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QA Manager - Eindhoven

Function Group: Quality/RA

Organization

QTC Recruitment is currently looking for a QMS Manager for a temporary contract until the end of the year. Our client is a global, leading medical devices company based in Eindhoven, the Netherlands.

Function

Your challange

To assure the Quality and Safety of Innovative (Medical and Non-Medical) products in a Dynamic Environment. Key challenges include risk management, design quality assurance activities and co-ordination of quality activities with Engineering, procurement, manufacturing, clinical, service and support teams. Supports organisation to work compliant in a lean way.

Your responsibilities

  • Instruct, coach and facilitate project team’s Quality Management System (Procedures/ Policies/ Guidelines/ tools/ training, etc.).
  • Instruct, coach and facilitate project teams on relevant product standards (IEC60335/IEC60601/21 CFR820/ISO13485, etc.)
  • Drives and supports quality & regulatory compliance to assure products & services comply with the Quality Management System / Business Management System requirements
  • Create quality function deliverables as per Quality Management System in projects, in Life Cycle Management and in Post Market Surveillance.
  • Review Requirements Management process and outcome.
  • Reviews Product Verification and Validation
  • Ensure Risk Management quality (quality of UFMEA, DFMEA, PFMEA/HB-SRA, etc.).
  • Ensure compliance to quality system requirements, regulations and standards in designated area of responsibility.
  • Ensures timely execution and required communications and escalation.

Requirements

We are looking for

  • Bachelor degree with 5+ years of related experience or a Master degree with 3+ years of related experience.
  • Applied knowledge of appropriate global medical device or consumer product regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, and ISO9001.
  • Preferably experience in a medical device industry.
  • Proven ability to successfully incorporate and manage stakeholder needs throughout a project
  • Communicate globally, across teams and programs, from senior executives to administrative support personnel. Experience leading remote teams.
  • Both detail oriented and able to see big picture

you have explicit experience in

  • An R&D environment (product development)
  • Driving product Quality
  • Risk management
  • Product/Consumer Safety management
  • Well versed with ISO13485 / IEC60601 / ISO 14971


Information

Max Parijs +31 (0)23 754 8660

Application

Max Parijs
Consultant

+31 (0)23 754 8660
+31(0)6 8222 6854
m.parijs@qtcrecruitment.com

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