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QMS Manager - medical devices - Wavre

QMS Manager - Medical Devices - Wavre

General Description

The QMS Manager has the responsibility and authority for ensuring that efficient quality management processes are implemented, maintained and improved to comply to international quality standards and appropriate regulations. The QMS Manager is also responsible for the Supplier Management, Audit, Feedback, Management Review, Customer complaints, CAPA, Change Control and FSCCA

Detailed Description

  • Ensure that efficient processes related to QMS are in place, in use and comply to ISO 13485 and European MDR and, as appropriate to 21 CFR 803, 806 and 820, Canadian Food, Drugs, and Medical Devices Regulations (CMDR).
  • Constantly assess the QMS relevance and efficiency against the Company strategy, organization, Quality Policy, Quality Objectives and value creation
  • Assist QA management representative in reporting on the effectiveness of the QMS and need for improvement (Management reviews)
  • Assist QA Management representative in ensuring promotion and awareness of applicable regulatory requirements and quality management system requirements
  • Ensure normative and regulatory changes related to quality systems are identified in a proactive manner and establish action plans to proactively build continued compliance
  • Ensure the compliance of the reporting and post-market surveillance obligations in accordance with applicable standards and regulation
  • Lead and support supplier selection, qualification and evaluation
  • Lead and support internal and suppliers audit process
  • Ensure the compliance and Support Vigilance
  • Manage Electronic Management System
  • Establish budget contributing to the development of annual proposals for funding of the Quality function

COMPLIANCE/LEGAL RESPONSIBILITIES

  • Maintains the highest standards of ethics in all circumstances
  • Ensure compliance with the Company quality system and applicable guidance, standards and regulations.

Education

BSc degree in engineering (or equivalent)

Languages

English and French (other language is an asset)

Professional Experience

5 to 10 years in QMS management as Supervisor and/or Manager in Medical Device or consulting firms. Excellent knowledge of ISO 13485 and EU Medical Device Directive and EU Medical Device Regulation

Sound knowledge of risks management (ISO14971)

Experience of validation of special processes (cleaning, sterilisation…) and work environment (clean rooms)

Experience in managing quality audit (internal & external)

Experience in supporting elaboration of Technical Files

Personal Skills

Good team player

Very organized with sense of details and pragmatic

Good communicator but ability to say “no”

Travel

Limited (5%)

Offer

We offer a full-time permanent position along with an attractive remuneration package.

The position is based in Belgium (Wavre) with possibility to work from home a few days a week and has an international scope.

Headed by a solid management team, you will be part of a highly skilled (engineers, scientists) capable and dynamic team of innovative leaders with proven tracks records in the pharmaceutical and medical device industries.

We have an agile start-up company culture focused on values of entrepreneurship, engagement, integrity, passion and excellence.

Excited about the role?

To apply, please send your CV and a motivation letter to tvandewoestijne@plusonesearch.be

Publication date

07.04.2021

Contact person

Van De Woestijne

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