Quality Management Senior Specialist 100% m/f/d

☞ Zimmer Biomet EMEA

View: 164

Update day: 25-04-2024

Location: Winterthur Zürich ZH

Category: Quality Assurance / Quality Control

Industry: Medical Equipment Manufacturing

Position: Entry level

Job type: Full-time

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Job content

Founded in 1927 and headquartered in Warsaw, Indiana, USA, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopedic reconstructive products; sports medicine, biologics, extremities and trauma products; spine, bone healing, craniomaxillofacial and thoracic products; dental implants; and related surgical products.We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.For our production site in Winterthur (Switzerland), we are looking for a:Quality Management Senior Specialist 100% m/f/dYour Main Responsibilities
  • Maintaining and optimizing the Quality Management System
  • Responsibility for QMS compliance to all applicable regulations and standards
  • Responsibility for the Zimmer Biomet document / records management system
  • Review and approve processes and their training scope
  • Review and approve change requests
  • Creating and maintaining new procedures and work instructions
  • Supporting the development of electronic workflows and their testing
  • Coaching process owners in process improvement and process creation
  • Leading quality planning, CAPA and other projects
  • Monitoring training effectiveness and completion rate, delivering quality trainings
  • Coordination of training needs
  • Planning, performing and assisting internal, product and external audits
  • Performing internal trainings for audits
  • Supporting Management Review Meetings
  • Management of standards and regulations
Your Qualifications And Experience
  • Degree in business or engineering or professional experience in a similar position
  • Minimum 4 years of experience in the quality management system (preferred within a medical device company)
  • Lead auditor training with certification
  • Experience in procedure writing
  • Experience in document / record control and change management
  • Knowledge / background in medical device industry
  • Knowledge of applicable ISO Standards in particular ISO13485, ISO 9001, ISO14971, the European Medical Device Regulation (MDR) 2017/745, other relevant European directives and general knowledge of US Quality System Regulations (21 CFR 820) and MDSAP
  • Ability to train personnel
  • Excellent command in English and German both verbal and written
If you seize this opportunity, you will be able to develop your international experience and be a part of a great and truly global team. Zimmer offers a wide range of challenging career advancement opportunities and a dynamic work environment. We look forward to receiving your complete application through the following link.For this position, we accept direct applications only.Zimmer Switzerland Manufacturing GmbHKübra DurHuman Resources GeneralistSulzerallee 88404 Winterthurwww.zimmerbiomet.com
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Deadline: 09-06-2024

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