QA Project Engineer
Getinge Infection Control AB / Maskiningenjörsjobb / Halmstad
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hela Sverige Every day, Getinge Group products contribute to saving lives and ensuring excellent care. All across the world, our people make a huge difference for patients, healthcare professionals and societies. And we are very proud of that.
Getinge Sterilization AB is a production company within Getinge Group with approximately 260 employees. We develop and produce autoclaves that are used for infection control in hospitals, pharmaceutical industries and laboratories.
The position
We are now looking for a structured and improvement driven Quality Engineer to create a winning product life cycle process by ensuring compliance to regulatory requirements and internal processes during product development and maintenance projects, mainly within the Life Science (LS) area. This is a brand new position which will have a great impact on the success of our ongoing and future LS projects.
Your key responsibilities and work tasks include:
• Support development and maintenance of processes for LS development projects to ensure that the interpretation of regulatory requirements is performed to the correct level of compliance.
• Facilitate product and project risk assessments for LS projects
• Participate during installations at customer sites when applicable
• Monitor and control compliance to ATEX and RoHS 2 directives
• Review product assessments/working methods for LS products and update if applicable to ensure full regulatory compliance
• Ensure appropriate documentation of products according to customer and regulatory needs
• Ensure that latest version of specified product standards and directives are used during product development projects
• Assist the project with performing translations of regulatory requirements into technical solutions
• Review product documentation from a QA/RA perspective
• Act as Internal auditor
You will belong to a dedicated and professional team within Quality Compliance and report to head of QEM & RA.
National and international travel is expected to approximately 15-25 days per year.
The ideal candidate has the following key characteristics:
• A minimum of three years of experience from the Medical Device or Life science / Mechanical Industry, preferably within QA/RA and/or project management
• Minimum of three years of experience of working with interpretation/ translation of regulatory requirements into technical properties and technical documentation
• An academic degree within Mechanical and/or Electrical engineering
• Experience of technical documentation
• Experience of Design Control
• Experience of ISO 9001, ISO 14971, ATEX Directive 2014/34/EU, ROHS 2 Directive 2011/65/EC and Directive 2006/42/EC on Machinery is required
• Experience of ISO 13485, Medical Device Directive 93/42/EEC, PED 97/23/EC as well as Quality/Process Engineering. Lead auditor experience is beneficial
• Proficiency in Swedish and English, both in written and spoken
As a person you are a structured and organized team-player with excellent communication and problem solving skills. Having a supportive and coaching but also questioning attitude together with high integrity is crucial. We believe that you are motivated by making continuous improvements and that you see this as an exciting opportunity to contribute to the success of our projects and internal processes from a quality perspective!
Application
Are you interested in becoming part of an international and market leading medical technology company whose products make huge difference for patients, healthcare professionals and societies all around the world? Getinge offers a great opportunity to make a difference in a global and dynamic environment!
Welcome with your application no later than October 7th if you are interested in the position.
You are also welcome to contact Annika Fahlén at + 46 (0)10 335 5517 if you have questions.
Getinge Group is a leading global medical technology company with operations in the areas of surgery, intensive care, infection control, care ergonomics and wound care. The Group is organized into three business areas: Extended Care, Infection Control and Medical Systems, and operates under the ArjoHuntleigh, Getinge and Maquet brands.
We employ nearly 16,000 talented employees across the globe who delivers innovative products and solutions that contribute to quality enhancement and cost efficiency within healthcare and the life sciences. At Getinge Group you are involved in the creation of sustainable healthcare for future generations.
Getinge Group is active in over 40 countries and generates sales of about SEK 27 billion. We are expanding rap
Varaktighet, arbetstid
Heltid Tills vidare
Publiceringsdatum2015-09-16ErsättningFast
Så ansöker duSista dag att ansöka är 2015-10-07
Klicka på denna länk för att göra din ansökanFöretagGetinge Infection Control AB
AdressGetinge Infection Control AB
Box 69
30505 Getinge
KontorsadressBox 69
Jobbnummer 2431766
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