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 experts in a team environment.
- Leads and manages the execution of objectives for the control of external suppliers, and service providers in alignment with corporate goals and objectives 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 monitoring ratings and uncooperative suppliers
- Review and approves supplier records including but not exclusive to: contracts, quality plans, change requests, SCARs/CAPAs, NCRs, verification and validation protocols and reports.
- Perform External Supplier Audits
- Participate in critical decision-making meetings as required to define Suppliers roles, responsibilities and effectiveness
- B.S. Engineering, Biological Sciences, Chemistry, Biochemistry or equivalent.
- Masters of Science Degree a plus
- 7 years+ experience in Supplier Quality
- 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
- ISO 13485 Lead auditor training and certification preferred
- International travel/foreign business exposure a plus
- A certification / documented 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.
- Multilingual, ability to speak and write in local language on a professional level.
- Travels, in average 30%, within the country and region and abroad when required.
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.
To Apply, please click the following link: https://thermofisher.contacthr.com/75742062
Apply on company website