Quality System Specialist
Dfind Science & Engineering AB / Kemistjobb / Stockholm
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Sökord: ISO 13485, kvalitetssystem, Interninspektion, FDA, internal audit, IVD, kvalitetsingenjör, QA
The Quality department at Cepheid is growing and is therefore looking for a Quality System (QS) Specialist. As a QS Specialist you will play a key function to plan and implement the upgrade of the Quality system to new ISO standards and applicable regulations for in vitro diagnostics, with a continuous communication with US and European Cepheid sites.
Work responsibilities
• Participate to the definition of annual quality goals and quality plans
• Develop tools for QS activities monitoring and follow-up
• Create cross-functional teams including QA and process owners to facilitate QS upgrade to new regulatory requirements
• Promote and develop standard work and documentation to optimize QS processes (standardization and simplification)
• Approve QS document changes
• Plans and coordinate activities related to the internal audit program
• Work with process owners to identify and implement improvements of the Quality System processes
Qualifications:
• University degree in engineering, science or equivalent.
• At least three years of experience in Quality Assurance, in the medical diagnostics / pharmaceutical industry
• Knowledge of risk management tools (FMEA, FTA etc..)
• Experience in QS audit process
• Excellent skills in Swedish and English both in written and verbally
• Experience of In Vitro Diagnostics and ISO 13485
To be success full in this role we think that you have personal attributes such as:
• Strong leadership and excellent communication skills
• High level of interpersonal skills
• Self-motivated with ability to own initiatives
• High adaptability and flexibility
• Careful and thorough
• Lead, Push and follow up to ensure forward progress in Projects
• Delegate responsibility
• Ability to keep overview and keep focus
• Influence others
• Excellent organizational skills
• Multi-tasking ability
• Systematic
• Ability to successfully manage cross-functional teams
Business: Cepheid
City: Solna
Employment: Open ended full time
Last date of application: 2017.08.31. The selection will be done continuously so don't wait with your application.
For information: In this recruitment Cepheid is collaborating with Dfind Science & Engineering. For questions please contact responsible recruitment consultant Ellinor Crafoord 0733-434502. Apply via
www.dfind.se/science-engineering as soon as possible.
Organization and Business description:
Cepheid is one of the fastest growing companies in molecular diagnostics. The company's unique diagnostic platform is used throughout the world, making a difference for patients as diagnosis and choice of treatment is facilitated by the test results. Cepheid offers a broad range of diagnostic products in virology, bacteriology and oncology that can meet tomorrow's demands for safe, fast and flexible diagnostic both in Western countries and in countries with limited resources. Globally, the company is represented by its headquarters in Sunnyvale, California, sales and marketing offices in Toulouse, France and technology and chemistry center in Bothell, Washington. Cepheid AB, part of the global Danaher group, is located in Solna, Sweden and has around 250 employees, mainly in production, quality control, research and development.
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Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2017-08-17ErsättningFast lön
Så ansöker duSista dag att ansöka är 2017-08-31
Ange följande referens när du ansöker: 201074685
Klicka på denna länk för att göra din ansökanKontaktEllinor Crafoord
FöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Regeringsgatan 65
10724 STOCKHOLM
KontorsadressRegeringsgatan 65, 10724 STOCKHOLM
Jobbnummer 3647879
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