Quality Manager

il y a 2 semaines

Guyancourt, Île-de-France Edwards Lifesciences Temps plein

Imagine how your ideas and expertise can change a patient's life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You'll bring your passion for problem solving and partner with various teams to influence decision-making for a product's entire lifecycle. Your work will involve you optimizing post-market quality to impact patients around the world with pioneering technology. In this role specifically you will work to improve and implement quality systems processes, including applications, documentation and training. The role is office based in our office in Guyancourt, with remote working included and it will require approximately 10% availability to travel.

How you'll make an impact:

  • Identify, lead and provide business process improvement solutions for Quality Systems, including reviewing and approving changes to procedures, to improve operation, efficiencies, and user experience
  • Lead moderately complex projects from inception through completion, including developing and/or scheduling key milestones, securing and allocating resources, and representing quality management on cross-functional teams
  • Manage all phases of small to medium quality systems (e.g., CAPA, NCR, Supplier)
  • Review and approve changes to documentation associated with Quality Systems, as well as assessing effectiveness and approving recommendations of others
  • Drive investigations of basic problems, perform robust root cause analysis, develop and implement corrective actions, and establish monitoring plans in collaboration with cross functional Subject Matter Experts
  • Review and identify actions from metrics
  • Prepare and pre-review data and documents for integrity prior to presentation in internal and external audit activities
  • Provide technical direction to lower level staff
  • Other incidental duties.

What you'll need (Required):

  • Bachelor's Degree or Equivalent in related field.
  • 7 years' experience on quality and/or manufacturing environment in the medical device industry.
  • Experience with Quality Systems and Audits Preferred.
  • Fluent in both French and English.

What else we look for (Preferred):

  • Proven successful project management skills
  • Proven expertise in MS Office Suite
  • Excellent facilitation and presentation skills, showing great communication skills
  • Excellent problem-solving, organizational, analytical and critical thinking skills
  • Excellent documentation and interpersonal relationship skills including negotiating and relationship management skills
  • Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards
  • Extensive knowledge and understanding of medical or pharmaceutical regulations as relating to documentation
  • Extensive understanding of medical devices regulations (e.g., FDA (21 CFR Part 820), ISO13485, and ISO 14971)
  • Ability to transfer essential knowledge and mentor other team members on specialized skills
  • Strict attention to detail
  • Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
  • Ability to manage competing priorities in a fast-paced environment
  • Ability to represent leadership on sections of projects within a specific area interfacing with project managers and quality systems team
  • Ability to consult in a project setting within specific sections

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