compliance specialist // johnson & johnson à Zuchwil

Stefanie Aerni, Randstad Inhouse Services Actelion
type d'emploi
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job details

zuchwil, soleure
type d'emploi
stefanie aerni, randstad inhouse services actelion
058 231 36 15

description du poste

Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 260 operating companies in more than 60 countries employing approximately 134,000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.DePuy Synthes Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the world. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials. Our broad array of inspired, innovative and high-quality offerings, help advance the health and wellbeing of people around the world.

Main Responsibilities

As part of the Regulatory Compliance team of DePuySynthes, this role provides Quality System Compliance support to the assigned site(s). This includes the procedures and records required for the development, deployment and maintenance of quality system processes in order to assure the ongoing compliance with ISO13485, FDA QSRs and the Medical Devices Directive and other applicable regulations and standards.

  • Ensures that all activities are carried out in compliance with all applicable regulations, policies and procedures governing business and quality operations
  • Ensures all assigned quality actions, and all internal and external audit observations are investigated, have causes identified, action plans completed, and appropriate effectiveness monitoring
  • Keep up to date with all new legislation and regulation standards for applicable all countries and ensure compliance to any changes to these across the facility
  • Implement harmonized J&J and MD&D Compliance Standards and SOPs
  • Establish and maintain regulatory inspection readiness plans for assigned sites
  • Act as site EtQ Audit module support
  • Creation, deployment and Maintenance of the internal audit schedule
  • Perform required audits in accordance with defined procedures and the master schedule; identify and perform 'for cause' audits
  • Ensure proper internal audit reporting, response review and approvals, communication of issues, and use of tracking and trending tools
  • Train and maintain users on the Audit system
  • Drive Compliance improvements, which result from internal audits, Quality Board Issues and other system indicators
  • Provide Front Room/ Back Room support during external audits
  • Coach and guide Quality System Auditors and support staff as required to ensure appropriate control systems are in place and continually optimized to meet changing regulatory, corporate and industry standards
  • If required assist other facilities for both external audit prep and assistance during their external audit


Who we are looking for

  • At least Bachelor degree in Science, Engineering, Quality or other technical field
  • Equivalent degree and/or adequate associated work experience is acceptable
  • At least 4 to 6 years working experience in a regulated industry
  • At least 1 year experience in a quality and/or compliance function
  • Extensive knowledge of Quality Systems (21 CFR 820/ISO 13485) within a regulated environment
  • Experience in performing audits is required
  • Experience in interaction with Health Authorities and Notified Bodies is required
  • Fluent in English, French is a big plus

This role based in Zuchwil, Switzerland will initially be limited to approx. 12 months. If you are interested in working for a global leading health care company in a challenging role, then send us your application in English today. Or give us a call if you have any questions!