Job Description

As a Supplier Quality Engineer III, you will lead the supplier quality function, also ensure compliance, drive supplier continuous improvements and reduce risk in our supply chain. You will also participate in solving supplier quality issues and lead quality audits as part of the Global Supplier Quality team. You will update Supplier Quality procedures and processes in compliance with ISO 9001/13485, FDA, GMP and other external requirements.

What will you do?
Key Responsibilities:

Supplier Evaluations

* Lead supplier evaluations (desk/remote/on-site) to applicable standard/requirements
* Manage tier definitions of suppliers and set tier level of suppliers
* Maintain the approved suppliers list
* Conduct the execution of objectives for the control of external suppliers

Supplier Quality Issues

* Collaborate with Procurement, Quality and Operations to define actions and priorities for supplier related quality issues
* Drive problem solving and root cause analysis activities with suppliers to investigate and eliminate recurrence of non2010conformances
* Act as the liaison for suppliers on behalf of quality and purchasing, on supplier issues and work with the suppliers to develop quality and process improvements while collaborating with internal subject matter experts
* Actively participate in strategic supplier development based on risks identified through Supply Chain Risk Mitigation team
* Review and approve supplier records, non-conformance and corrective action reports

Documentation and Reports

* Update Supplier Quality procedures in compliance with applicable ISO 13485/9001 and GMP requirements, as required
* Conduct Quality Agreement negotiations with suppliers

Reporting to Management

* Support and achieve Supplier Quality objectives
* Report to management the supplier performance metrics while monitoring ratings and uncooperative suppliers
* Participate in strategic supplier development based on risks identified through Supply Chain Risk Mitigation team

Other Responsibilities

* Support teams for new material qualification, product development, material changes and end of life projects
* Work according to procedures and provide direction to other departments
* Present Supplier quality processes to internal and customer audits
* Establishes quality benchmarks and metrics for measuring, analyzing, and improving supplier performance and cost of poor supplier quality.
* Actively participate in the production part approval and FAI (First Article Inspection) processes to ensure compliance to engineering specifications and requirements.
* Other duties as assigned

How will you get there?
Education Requirements:

* Bachelor2019s degree in Engineering, Manufacturing, Operations Management, or equivalent required
* ASQ Certified Quality Engineer preferred
* Certified Green or Black Belt preferred
* Certified Quality auditor preferred

Experience Requirements:

200B200B200B200B

*

* At least 3-years of experience in Supplier Management required
* Experience in leading Supplier Quality audits preferred
* Experience with quality standards and regulations such as ISO 13485 or ISO 9001 and/or 21 CFR Part 820, 210, 211, MDSAP preferred
* Knowledge of quality and statistical tools such as 8D, FMEA and Pareto Analysis, SPC preferred
* Experience with electronic (printed circuit board assemblies), electrical, and electro-mechanical commodities.
* Excellent oral and written communication skills in English required
* Demonstrated expertise to effectively manage projects and problems, and communicate within all levels of the organization
* International travel / foreign business exposure is preferred
* Good Microsoft Office skills required
* Good presentation skills required

Working Contacts:

* Regular contact with local and global departments and functions, primarily quality and purchasing
* Frequent interaction with suppliers

Working Conditions / Travel Requirements:

* Office based
* Travel required (domestic/international) by plane, rail and car (up to 25%)
* Visits to Thermo Fisher sites and supplier premises (e.g. factories, laboratories) wearing of PPE (Personal Protective Equipment)
*