Senior Quality Engineer - Cestas, France - Stryker

Stryker
Stryker
Entreprise vérifiée
Cestas, France

il y a 2 semaines

Sophie Dupont

Posté par:

Sophie Dupont

beBee Recruiter
Description

Senior Quality Engineer - temporary assignment


Provide quality engineering support and direction in quality assurance, control and preventative activities within operations and other business functions with a focus on continuous improvement of products and processes (internal and supplier).

Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers.

Ensure compliance to regulation and standards.

You will work within the quality operations team, under moderate supervision and mentoring, with responsibility for quality related activities (internal and supplier), including, but not limited to the following:

  • Work closely with operations and the business functions to ensure quality performance of product and processes
  • Collaborate with Divisional QA, crossfunctional and suppliers' teams to address top quality issues
  • Own, oversight and approval of NC & CAPA, activist and mentor in problem solving and root causing activities
  • Disposition nonconforming product within MRB, issuing NC's as appropriate
  • Communicate & collaborate with suppliers regarding nonconformances, escalating supplier corrective action requests as required. Lead the solving of supplier quality issues impacting daily operations
  • Lead and participate in the development and improvement of the manufacturing processes for existing and new products
  • Review and approval of internal and supplier proposed change management activities and PPAP activities for supplier changes
  • Participates and leads the creation and/or review of new or modified procedures
  • Initiate KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary
  • Support execution and analysis of manufacturing related complaints and product field actions (PFA)
  • Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation
  • Collaborate with appropriate stakeholders to identify and execute opportunities for supplier part certification
  • Proficient in risk management practices and tools, having high expertise in process risk. Develop and provide input for risk management by identifying opportunities and weaknesses
  • Support the creation and maintenance of inspection methods and sampling
  • Participate and interface in internal and external audits with regulatory representatives providing effective narrative and description of topic of expertise
  • Assist in the development, responsible for review and approval of process and equipment validation/qualification and MSA of internal processes
  • Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities
  • Responsible for initiation, internal containment, communication and support of Commercial Holds for potential product escapes
  • Support execution and analysis of QATs
  • Support First Article Inspections

What you need:


  • Engineering studies with 2 or more years of experience in biomedical or regulated environment
  • Proven previous experience in industrial quality environment (production, engineering), experience in supplier management is a plus
  • Systems: experience in quality tools, NC/CAPA management as well as project management, Qualification/ Validation process knowledge
  • Good communication skills, capable of influencing without authority, good organizational skills, leadership, critical thinking, high responsiveness
  • Languages fluent in French & English
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