(Sr.) Medical Device & Diagnostics Expert

19/11/20

Location

Georges Van Dammeplein 57 Temse Belgium

Function type

(Sr.) Medical Device & Diagnostics Expert

Vacancy

You bring in expertise and experience in one or more of the following domains related to Medical Devices & Diagnostics: Regulatory, Compliance, Quality, Operations and Supply Chain. You are a trendwatcher, following the latest updates in regulations and technologies.

You will

  • function as an expert in one or more of the following areas of expertise: Regulatory, Compliance, Quality, Supply Chain Operations and Industry 4.0

  • ensure regulatory compliance (ISO, MDR, MDSAP, …) by defining the roadmap towards audits

  • be responsible for leveraging quality processes and implementing quality systems

  • prepare and validate quality document templates, such as SOPs, WIs, …

  • provide frequent updates on what’s happening in the Medical Device & Diagnostics industry to your colleagues and related CoE

  • develop and elaborate best practices

  • initiate quality and/or industrialization optimization projects by using the right improvement techniques

  • work in the broader MedTech industry going from start-ups to global multinationals

You are

  • a Master of Sciences (Biosciences, Biomedical sciences, Biology, Pharmaceutical sciences, Chemistry) or a Master of Industrial or Civil Engineering

  • able to approach challenges and solve problems in a methodical manner

  • a strong communicator both in writing and verbally

  • stress-resilient, solution-oriented and able to cope with change

  • able to think outside the box

  • proficient in English

  • familiar with Office 365

  • trusted with GxP (GLP, GMP, …)/validation/qualification

  • certified in ISO standards (such as ISO13485, ISO9001, ISO62304, ISO14971, …), IVDR, MDR, MDSAP and/or other guidelines (e.g. 21 CFR part11/part 820, …)

  • experienced in QMS implementation

  • familiar with development of SOPs, related WIs, forms, checklist, protocols, and reports

  • skilled in one or more Supply Chain domains

Cherry on the cake

  • certified CAPM/PMP/Prince2/ AgilePM/ScrumMaster or by experience

  • knowledge of PM tools (Planisware, MS Project, Wrike, Planview …) 

  • Lean Management (green or black belt)

  • APICS BSCM/CPIM/CSCP/CLTD certified

  • user experience in QMS systems (such as VEEVA or other)

  • basic knowledge of AI, big data and/or augmented analytics

  • Dutch and/or French knowledge

Job application