Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $35 billion and approximately 90,000 employees in more than 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. Through our world-class brands ? Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services ? we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support!

This position will drive ISO 13485 compliant Supplier Quality processes and improvements for our commercial organization, Thermo Fisher Diagnostics, which covers sales and marketing, distribution, import, warehousing, customer services and technical field service operations for diagnostics medical device products and related industries.

Summary of Key Responsibilities and Function

As a Supplier Quality Lead, you will drive improvements and reduce risk in our Distribution Supply Chain. This role is a primary leader/manager of processes for qualifying new suppliers, analyze and improve supplier performance, implement corrective actions or quality plans at supplier sites to prevent repeat non-conformances using Quality Tools (8D, FMEA, CpK, GR&R, SPC, etc.) and perform supplier audits. Develops and updates procedures & processes in compliance with ISO, FDA and other external requirements. Actively participates in strategic supplier development based on risks identified through Supply Chain Risk Mitigation team. Manages the supply chain, serves as the liaison for suppliers, suggest structural quality and process improvements while collaborating with other subject matter authorities in a team environment.

Key Responsibilities:

• Leads and runs the execution of objectives for the control of external suppliers, and service providers for Thermo Fisher Diagnostics

• Direct team member supporting and executing Supply Chain Risk Management process and mitigation activities

• Drives continuous supplier management improvement with procedures, processes, policies and quality assurance methodologies including but not exclusive to: new material qualification, end of life materials/components, product development process, supplier requests for material changes and sustaining engineering

• Collaborates with Procurement and Operations to effectively define roles and responsibilities and supply priorities and actions

• Ensures the Supplier Quality function operates according to procedures and provides direction to other departments. Is a champion of problem solving and root cause analysis activities with suppliers and customers to eliminate recurrence of non?conformances

• Collaborates with the Procurement team assigned to support supplied products and materials. Develops long?term supplier relationships, generates and implements cost reduction ideas. Reports supplier performance while supervising ratings and uncooperative suppliers

• Review and approves supplier records including contracts, quality plans, change requests, SCARs/CAPAs, NCRs, verification and validation protocols and reports.

• Perform External Supplier Audits

• Participate in critical decision-making meetings to define suppliers roles, responsibilities and efficiency

Minimum Requirements:

• B.S. Engineering, Biological Sciences, Chemistry, Biochemistry, or equivalent

• 5 years+ experience in Supplier Quality

• Knowledge of IVD regulations

• Experience working with Supply Chain Risk Management processes and tools

• Solid experience with IS0 13485 or IS0 9001 and/or 21 CFR Part 820

• Excellent oral and written communication skills

• Proficiency in English; any additional European language is a big plus

Preferred Requirements:

• A certification / detailed training in auditing of quality systems; ISO 13485 and or ISO 9001.

• Significant experience within key regulatory and quality systems processes, such as; Complaint management, CAPA, supplier control, auditing, regulatory compliance, risk management and or IT quality system applications.as well as technical expertise within technical field service and or warehousing.

Travel Requirement:

• Travels, in average 30%, within the country and region and abroad

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.

Please apply with CV and cover letter in English!