Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
The Thermo Fisher Scientific HPLC business has been setting decisive and innovative trends for many years in the development, manufacturing and marketing of instruments and software for High-Performance Liquid Chromatography (HPLC). The expertise of our highly qualified staff contributes significantly to our economic success, enabling us to continuously expand our site in Germering near Munich.
For the support of our Team we are looking for a
Quality Management System Specialist (f/m/d)
Discover Impactful Work:
As the Quality Management System Specialist (f/m/d) you are part of the Chromatography and Mass Spectrometry Software Division (CMD) and will have primary responsibility for running the CMD Software Quality Management System (QMS) at Global level. You'll lead all aspects of the global CMD Software QMS and work closely with colleagues from R&D, Product management, Sales, Installation Services.
This role provides daily support in maintain the QMS effective throughout the organization. In addition, this role will serve as the Management Representative for CMD during external audits where CMD requires representation.
A day in the Life:

• Responsible to maintain the CMD Software Quality Management System up to date, by running:
  • The scanning of external regulations pertaining to ISO9001; ISO27001 and other regulations relevant to the software business.
  • Documentation: SOPs creation, revision and maintenance of a harmonized multisite Quality system.
  • Training programs and plan
  • Internal and Supplier Audits program and ensures that observations are addressed (root cause identification, implementation, and closure)
  • Management reviews
  • Risk register and follow up actions to reduce/mitigate risk
  • Quality Agreements (internal, suppliers and customers)
• Responsible to maintain vital multi-site certification (for e.g. but not limited to ISO 9001, ISO 27001)
• Ensure the roll-out, usage and maintenance of eQMS tools (for e.g. but not limited to TrackWise, Oracle Cloud)
• Hosts Customer and external audits (e.g. ISO 9001) and ensures that observations are addressed (root cause identification, implementation and closure) and reported back timely to auditor
• Engage in quality initiatives to continuously elevate the quality culture and drive process improvements
• Role models 4-I values Integrity, Intensity, Innovation, Involvement and builds an environment that encourages others to demonstrate the 4-I values.

Keys to Success:
Education

• BA/BS degree in Engineering or may years of relevant experience

Experience

• Profound experience in Quality and/or related technical degree preferred
• Expertise in running a Software Quality Management System (QMS) at global level
• Solid understanding in ISO9001:2015 and industry specific standards
• Experience with ISO13485 preferred

Knowledge, Skills, Abilities

• Strong written and oral communication skills, with the ability to collaborate and communicate optimally both externally and throughout the organization
• Skilled at analyzing data and summarizing results, as well as generating performance metrics to drive improvement
• Enjoys working independently and as part of a team, self-motivation, adaptability and a positive attitude
• Diligent, organized and accurate
• Successful with influencing and driving results
• Able to prioritize to meet objectives

What we offer:

• Employment with an innovative, future-oriented organisation
• Outstanding career and development prospects
• Company pension scheme and other fringe benefits
• Exciting company culture which stands for integrity, intensity, involvement and innovation

If you are interested, please apply online with your CV and Motivation Letter including possible start date and salary expectations.
At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission?enabling our customers to make the world healthier, cleaner and safer.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or any other legally protected status.
Apply today! http://jobs.thermofisher.com
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