Quality Manager

  • Salary: Competitive
  • REF Number: 00049202
  • Consultant: Jocelyn Blackham
  • Contact: 0041 (0) 782 516 595
  • Date Published: 05.11.2020
  • Sector: Medical Devices
  • Location: Canton of Lucern, Zurich/Zug Region
  • Discipline: Clinical - Regulatory Affairs

CK QLS are recruiting for a Quality Manager to join a family run company in the medical device industry at their site based in the canton of Lucern on a permanent basis.

Quality Manager Role: The main purpose of the role will be to:

  • Act as theprocess owner for the Design Control (DC) process for medical device development according to ISO 13485.
  • Play a key role in the Product Risk Management (RM) process according to ISO 14971.
  • Act as the representative for the processes and Design History Files (DHF) in internal and external audit.

Further responsibilities will include:

  • Management and documentation of product designs (DHF), design changes, product related corrective actions (CAPAs) and product phase outs.
  • Management and documentation of product risk files.

Your Background: In order to be considered for this role, you will be required to have the following qualifications, skills and experience:

  • Advanced education (e.g. bachelor, master, dipl. Ing.) in life science, pharma technology or equivalent.
  • Experience in medical device development, DC and RM.
  • Experience in DHF, CAPA and RM file documentation.
  • Interdisciplinary communication; fluent in English (written and spoken), German of advantage.

This is an excellent opportunity to join a global leader in its field.

Apply: For more information or to apply for this Quality Manager position, please contact Jocelyn Blackham on 0041 (0) 782 516 595 or email jblackham@ckqls.ch, quoting job ref 49202.

Please could you send any correspondence in English.

It is essential that applicants hold entitlement to work in Switzerland.

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