CAPA Quality Manager - permanent role - Swiss Medtech with strong growth plans - English plus German beneficial
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 signficant boost this year, they are now supplementing that with a NC/CAPA specialist to take up a permanent position on site.
On a day to day basis this role entails documenting Nonconformances and CAPAs, and managing their analysis (Failure Investigation / Root Cause) and resolution (Action Plans and Effectiveness Monitoring (EM) Plans) within strict timelines, while providing overall support in terms of trending on failure modes and defects, and implementing NC and CAPA software tools and training programs. While the emphasis is on closing off CAPAs, the attitude is one of becoming more proactive as a company in dealing with Quality issues, improving processes, and reducing the need for reactive responses.
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
Being able to work in English and German is highly desirable: The local language is German as is some documentation, while the parent company is American with English becoming more important over time
This is a new position, with excellent potential to develop your career within an international leader in the industry. If this role seems a good fit, please apply by sending in your CV in WORD format with employment records (Zeugnisse) and Training certifications.
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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