CAPA Quality Engineer - permanent role - Swiss Medtech with strong growth plans - English and German both needed
Our client is a developer and manufacturer of high risk Medical devices, based in an exceptionally scenic area of German Switzerland. Currently they are experiencing major growth, in part due to demand for their products, in part due to significant investment by their American parent. With their quality department already receiving a significant boost this year, they are now supplementing that with a NC/CAPA specialist to take up a permanent position on site.
The perfect candidate would already be working (or has worked) as a CAPA specialist within the Medical Devices sector - owner & coordinator, responsible for deciding what NCs warrant a CAPA to be raised, participating in the actual investigation, discussing issues with engineers and local SME's, and resolving these within strict time-lines. Quality Engineers with strong CAPA experience will be considered, as will Quality professionals from other tightly regulated sectors (automotive, aerospace, Railways, Pharma), providing they have a knowledge and understanding of the recent changes in regulations within the Medical Devices sector.
German is an important requirement as discussion of technical issues WILL be in German, while English is the language of the parent company and will progressively become more important.
Typically this person will have a degree in engineering or science, worked in Quality Assurance wrt manufacturing Medical Device products for several years, with hands on experience as a Quality Engineer / CAPA specialist in accordance with ISO 13485, ISO14971, and 21 CFR Part 820. Further experience in root cause investigation techniques, corrective and preventive action planning and effectiveness verification and monitoring techniques will help, as will previous use of software tools Grand Avenue and Trackwise
This is a new position, and with the rate at which the company is recruiting, has excellent potential to develop your career within an international leader in the industry. If this role seems a good fit, please contact me NOW on 0041 43 50 80 817 for a confidential discussion of individual opportunities, and send in your CV in WORD format with employment records (Zeugnisse) and Training certifications to email@example.com
KEY WORDS: Quality Assurance, QA, Quality Engineer, Quality specialist, Compliance, Auditor, Medical Devices, Switzerland, ISO 13485, ISO 9001, GMP, ISO 14971, CAPA, corrective action, preventative action, root cause, Failure Investigation, Grand Avenue, Class III, Trackwise German, English, Medical Device jobs, nonstop recruitment.
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