Job Title : Quality Management System & Software Specialist
Location : +1 plaatsThuiswerken
Company : Thermo Fisher Scientific
Salary :
Open Date : 2023-01-01
Close Date : 2023-05-01

At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

How you will make an impact

As the Quality Management System & Software Specialist 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.

What you will do

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.

• 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.

Your skills and experiences

• BA/BS degree in Engineering or 10+ years’ experience preferred in Quality and/or related technical degree preferred solid understanding in ISO9001:2015 and industry specific standards; experience with ISO13485 preferred
• 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

Benefits

• We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company pension, and a range of employee benefits!
• Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

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, protected veteran status, disability or any other legally protected status.

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