Quality Management System Lead Auditor
Thermo Fisher Scientific / Kemiingenjörsjobb / Uppsala
Observera att sista ansökningsdag har passerat.
Visa alla kemiingenjörsjobb i Uppsala,
Östhammar,
Sigtuna,
Österåker,
Håbo eller i
hela Sverige Visa alla jobb hos Thermo Fisher Scientific i Uppsala,
Stockholm,
Huddinge,
Göteborg,
Ängelholm eller i
hela Sverige Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Our four premier brands - Life Technologies, Thermo Scientific, Fisher Scientific and
Unity Lab Services - offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please
visit
www.thermoscientific.com/phadiaQuality Management System Lead Auditor, Global Quality Assurance
Reports to: Director, Global Quality Assurance
Group/Division: SDG/IDD
Career Band: IV
Job Track: Professional
Position Location: Uppsala, Sweden
Number of Direct Reports: 0
Position Summary
You are responsible for ensuring compliance of regulatory directives and standards applicable to the medical device and in vitro diagnostic industries as relevant for all markets being served. This position will work closely with the entire organization to ensure compliance. This position will act as Quality Management System Lead Auditor, arranging for site inspections, conducting external supplier and internal audits as well as auditing commercial units. The position reports to the Director Global Quality Assurance.
Key Responsibilities
• Ensure compliance with medical device and in vitro diagnostic regulations, directives and standards.
• Be well versed in and constantly keep yourself up-to-date on applicable regulations, guidelines and standards.
• Maintain electronic files of audits.
• Complete requests for Vendor/Supplier Questionnaires.
• Plan and follow up of the yearly audit program.
• Perform audits according to the audit program.
• Responsible for maintenance and development of the audit process.
• Establish and monitor KPI/PI for the process, providing reports to senior management.
• Plan and coordinate inspections conducted by authorities and customers.
• Take on ownership for specific business processes as assigned.
Requirements/Qualifications
• University degree in medical/technical sciences.
• Minimum of 5 years work experience in a medical regulated industry.
• Experience from quality management systems in an IVD/Medical device environment, e.g. QSR, EU medical directive, ISO 13485, ISO14001, ISO14971, etc.
• Significant experience in analyzing and interpreting regulations, directives and standards.
• Certified Quality Management System Auditor or equivalent.
• Minimum of 3 years' experience of conducting Quality audits.
• Excellent verbal/written communication skills; fluency in Swedish and English preferred.
Personal skills
• Ability to influence others, fostering integrity and being persistent
• Creative, with analytical problem solving skills
• Strong Communication skills
• Complete finisher
For further information please contact:
• Kristina Berglund, Global QA, +46 18 16 38 90
• Annika Berg, Vice President, Global QA/RA, +46 18 16 65 51
• Håkan Olsson, HR Director, +46 18 16 53 46
Varaktighet, arbetstid
Tillsvidare
Heltid
Publiceringsdatum2015-04-17ErsättningFast månads- vecko- eller timlön
Så ansöker duPlease send your application with CV and marked reference no. 31 to
hr.idd@thermofisher.com no later than April 27.
Ansökan kan skickas till e-postadress:
hr.idd@thermofisher.comFöretagThermo Fisher Scientific
AdressThermo Fisher Scientific
Box 6460
75137 UPPSALA
KontorsadressRapsgatan 7P
Övriga kontaktuppgifterTelefonnummer: 018-165000
E-postadress:
hr.idd@thermofisher.com Jobbnummer 2252392
Observera att sista ansökningsdag har passerat.