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Job Details

Position Summary (12 to 18 month fixed-term contract)

Provide a quality engineering support to perform the activities to ensure Stryker will meet the new EU-MDR requirements and related timelines.

Position Requirements

Will work within the quality operations team dedicated to the EU MDR Project. You are responsible to perform activities to be compliant to the new EU MDR regulation.

Key areas of responsibility:

  • Complete the Technical Documentation for the Manufacturing information.
  • Complete QA activities following the EU-MDR regulation (drawing approbation, update Inspection Forms, Etc.).
  • Collaborate with suppliers and support them to ensure Stryker will meet the new EU-MDR requirements.
  • Assess and identify gaps regarding the regulation.
  • Support the remediation activities.
  • Review and approve the change management activities regarding the DPM activities.

Qualification Knowledge Skills

  • Engineering/Science licence and 3 or more years work experience in a quality discipline or
  • Engineering diploma (diplôme d'ingénieur) with 0 years
  • Familiarity with ISO 13485, GDP, GMP desirable.
  • Lean Six Sigma training a distinct advantage.
  • Previous experience in a regulated environment desirable.
  • CQE or equivalent course work / experience desirable
  • Proficient in understanding of Med Device manufacturing processes desirable.
  • Excellent communication skills and attention to detail.
  • Have a good understanding of engineering and quality practices & methods.
  • High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
  • Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
  • Must be willing to work as part of a multi-site team, with some travel required.
  • Working knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&Rs.
  • Highly developed problem solving and strong analytical skills.
  • Builds strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approach
  • Is diplomatic, tactful and leverages excellent interpersonal keys to help achieve outcomes.
  • Manages change well and adopts a continuous improvement orientation to the role
  • Excellent English (both oral and written)
  • Ability to be the voice of Quality when dealing cross functionally

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Ingénieur Qualité EU MDR (H/F)
I'm Interested