Supplier Quality Specialist

vor 6 Monaten

Freiburg, Deutschland Thermo Fisher Scientific Vollzeit

The Quality Difference at Thermo Fisher Scientific: What makes our quality teams unique is a shared passion for getting it done right the first time and working for the right reasons with our customers always in mind. Our team of Quality professionals understand our customers rely on the accuracy, safety, and effectiveness of our products and services that are improving lives around the world. When you join our team of quality professionals, you’ll collaborate on projects on a global scale while being encouraged to grow your skills and discover new career paths with us.
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.Location/Division Specific Information

Phadia is the leading supplier of fully automatic blood analysis systems for allergy and auto-immune diseases. With our innovative products, we set standards worldwide and assist clinicians in providing fast and reliable diagnoses, thus helping patients at an early stage. Phadia GmbH in Freiburg is the German subsidiary of the Immunodiagnostics division of Thermo Fisher Scientific, a global company that develops, manufactures and distributes in vitro diagnostics in the field of allergy and autoimmune diagnostics. Our customers expect a consistently reliable and high standard of quality from our products, which we ensure through innovative biochemical and medical technology solutions as well as highly qualified and motivated employees.Discover Impactful Work:
This role is responsible for ensuring compliance to regulatory requirements and standards applicable to the medical device and in vitro diagnostic industries as relevant for all markets being served. This position oversees and directs quality systems/compliance activities, provides quality management guidance to the entire site, as well as manages the QM team. The position reports to the Director Global Quality Assurance and serves as a key business partner, working closely with the entire organization to ensure compliance and product qualityA day in the Life:

- Support and collaborate in developing, updating and implementing processes in the quality management system for Supplier Quality to assure compliance to ISO 13485, IVDR and other applicable regulatory requirements.
- Risk based selection, classification, qualification, evaluation and monitoring of suppliers and subcontractors
- Risk based selection, classification, qualification, evaluation and monitoring of service providers
- Monitor and Improve Supplier Quality Performance (metrics) and lead periodic Supplier Quality Reviews
- Prepare and attend internal and external audits
- Support Supplier Audits
- Responsible for repository of Supplier Quality related documentation
- Supplier Change Management related to Supplier Change Requests
- Support and participate in Product Development and other projects related to selection, classification and qualification of suppliers.

Keys to Success:
Education
- A university degree in technical, medical, pharmacological sciences or corresponding work experience

Knowledge, Skills, Abilities
- Work experience from Supplier Quality, Quality Assurance or Purchasing, preferable in medical devices or pharma.
- Excellent verbal and written communication skills in German and English
- Ability to drive tasks and activities to closure in a timely fashion
- Ability to organize work and accomplish objectives
- Strong interpersonal skills

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
- 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.- Agency notice

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