Validation Engineer - Cochlear Bone Anchored Sol. AB - Logistikjobb i Göteborg
Validation Engineer
Cochlear Bone Anchored Sol. AB / Logistikjobb / Göteborg
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Cochlear Bone Anchored Solutions AB is a medical device company and the world leader within bone anchored hearing solutions. Its head office is based in Gothenburg. Cochlear Bone Anchored Solutions AB is part of the Cochlear group which is the world leader within hearing implants. The turnover for the total Cochlear group is 2,4 Billion SEK and the organization employs over 1100 people worldwide. You can log onto our website to learn more about how our product systems Baha® and VistafixT improves the quality of life for people all over the world. or

Cochlear is rapidly growing and will now employ a Validation Engineer to the Quality & Regolatory department. The main purpose of the role will be responsibility for developing and implementing validation relating to cleaning and sterilization of im-plants with the purpose to secure quality products and compliance of regulatory requirements. Some of your tasks will be:

* Develop plans and implement validation of cleaning and sterilization (irradiation) processes for manufacturing of implants
* Develop plans and implement validation of cleaning, disinfection and sterilization (autoclave) processes for reusable instruments
* Implement re-validation activities related to cleaning and sterilization
* Review and audit documents for validation of cleanrooms
* Assist global marketing in development of instructions for cleaning and sterilization of reusable instruments
* Actively taking part in product and process development projects related to implants with respon-sibility for validation
* Actively taking part in Design Reviews
* Actively taking part in Risk Analysis according to ISO 14971
* Participate at Supplier audits as validation specialist
* Participate in cross functional teams to monitor product and process quality for sterile compo-nents
* Actively monitor changes in regulatory standards for the area of concern to assure compliance
* Support local sales organizations by answering questions about cleaning and sterilization
* Provide advice and training on validation
* Develop quality policies and procedures relating to validation in collaboration with the validation team

You have an engineering or science degree and excellent English skills. You have at least three years of working experience from a regulated industry preferably manufacturing of Medical Devices and with vali-dation of products and processes and are familiar with the validation model. You have a good concern for order and quality and you like building relations. You are an independent person with a good driving force.

Apply for the job at latest November 5th. For more information contact Madeleine Hederstierna 031-807673.



Hederstierna, Madeleine

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Sista ansökningsdag 2007-11-05

Cochlear Bone Anchored Sol. AB
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