vacature kwaliteit

QMS Manager

Derks & Derks Detachering

A temporary position as QMS Manager for the period of 12 months at a global healthcare company

Offer
  • a challenging job within a global healthcare company
  • an operational role in a international environment
  • a temporary contract till June 2020
Organisation

Our relation is international active in the healthcare industry. They produce and sell their products to the international market. They are always looking for new innovative medical device products by investing in research and development. With this investments they hope to stay on top of the market. They design their products through the eyes of the end user combined with an appealing design. The organisation is always looking for improvement of their processes, therefore they like to get in touch with a QMS Manager.

Position

In the role as a QMS manager you provide Computer system Validation support to the E2E Program teams to ensure consistent compliance with optimization and efficiency in E2E processes. It is your main responsibility to act as a Validation Business Process Expert by acting in support of the Quality Assurance team and Q&R Business Process Owner, across the Q&R network for the E2E program. You will provide guidance, review and approval of validation deliverables including but not limited to tool Classification, Risk analysis, Part 11 assessment, Validation Plan, User Requirements Specification and Validation Summary Report. You report on status to E2E Q&R and Project management. You ensure that software applications and related infrastructures are validated for their intended use by a controlled and documented process in compliance with PMS, prior to issuance. Furthermore you participate directly as the Quality Management System Business Process Expert in the validation of applications, in integrated Landscape. Also you ensure compliance, efficiency and effectiveness of the processes within the sector, cross sectors, and at corporate. You also support setup and deployment of the Quality Management Systems along business model lines as identified by End-to-End teams. You will report to the head of the deparment.

Profile
  • Bachelor’s degree or equivalent preferably in a technical or engineering or/and IT related field(s)
  • minimum of 3-5 years of experience working in Quality Assurance / Quality Engineering / Quality Systems supporting multiple functional disciplines within a global medical (device/Pharma) industry
  • a comprehensive understanding of the diverse worldwide medical device quality regulations, including areas of device design, development, manufacture, distribution, worldwide device marketing, sales, service, and post-market surveillance
  • extensive knowledge of FDA QSR’s, ISO 13485, JPAL, China GMP’s and other worldwide Quality System Regulations
  • able to successfully communicate and educate Quality Management System regulations, policies and strategies to teams at all levels of the organization
  • knowledge of 21 CFR Part 210 , 211
  • experience in working directly with FDA/MHRA/ TGA/ ANVISA/other regulatory inspections
  • auditing experience, either in supporting or doing audits
  • awareness of Lean methodologies
Response

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/19-126-DD, to Sandra van Putten: info@derksenderks.nl. For further information, please call Sandra van Putten at number +31 (0)33 472 80 87.

An individual assessment may be part of the selection procedure.

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