Quality Assurance Specialist
NES Global Talent
Schaffhausen
vor 4 Tg.

Job Description

We are working in close cooperation with a Big Medical Device client who is currently expanding its Quality team in Schaffhausen.

Our client s portfolio consists of various different sterilization products.

Due to their fast expansion, they are currently looking for an experienced QA Specialist to provide support for the Product Life Cycle (LCM) and compliance with the company-wide quality management system.

This is a great opportunity for young professionals to gain deep insights into the Quality functions of a Medtech global player!

Technical Responsibilities

  • Operate in close collaboration with production and other stakeholder and assure a timely handling of all quality relevant topics and compliance with current FDA, EMEA regulations and ISO 13485.
  • Assure that all intermediate and final products manufactured for Production Medical Devices (PMD) meets requirements according to specification and current guidelines.
  • Assure that quality systems such as deviation system and change control system are consistently followed.
  • Escalate any issues which may impact on the compliance status or product quality
  • Batch disposition on product release through entire manufacturing and packaging process
  • In time Batch Record review and release
  • Batch release of semi-finished and finished goods
  • In time processing of products Complaint
  • In time processing of NCs and CAPAs for products.
  • Compliance to GMP, EHS and SOX specifications and guidelines associated with each function
  • Construction and review of quality documents (e.g. SOPS, Q-Agreements etc.)
  • Support and assess changes in area of responsibility
  • Filing and archiving of Batch documentation and samples.
  • NCs and complaints handling
  • Responsible for communicating business related issues or opportunities to next management level
  • Qualifications

  • 2- 5 years of experience in Pharma / Medtech industry
  • Strong GMP experience
  • Languages : German + English
  • If you are interested in this great opportunity or would like to know more then please apply now or contact Antony Polito at antony.polito nesfircroft.com.

    With over 90 years' combined experience, NES Fircroft (NES) is proud to be the world's leading engineering staffing provider spanning the Oil & Gas, Power & Renewables, Infrastructure, Life Sciences, Mining, Automotive and Chemicals sectors worldwide.

    With more than 100 offices in 45 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed.

    We offer contractors far more than a traditional recruitment service, supporting with everything from securing visas and work permits, to providing market-leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.

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