When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
The main focus of this role is to support the processes for qualifying new suppliers, analyze and improve supplier performance, implement corrective actions or quality plans internally as well as at the supplier to prevent repeat non-conformances using Quality Tools (FMEA, CpK, SPC, etc.) and perform supplier audits. The Supplier Quality Engineer develops and updates procedures & processes in compliance with ISO 9001:2015 and other external requirements. Actively participates in strategic supplier development based on quality control plans. Serves as the liaison for suppliers, suggest structural quality and process improvements while collaborating with other functions involved.
- Maintain and report meaningful supplier performance metrics to demonstrate the effectiveness of the supplier quality process and advising management of potential risks and make recommendations.
- Work closely with the Purchasing Team to select, qualify and develop suppliers by performing initial and periodic follow-up assessments/audits and assess suppliers against robust qualification requirements.
- 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.
- Review and approves supplier records including but not exclusive to: contracts, quality plans, change requests, CAPAs, NCRs, verification and validation protocols and reports.
- Act as Lead Auditor during supplier audits. Ensure management of supplier audits from planning to completion.
- Manage FAI (First Article Inspection) Process to ensure compliance to TFS requirements.
- Participate in design changes related to supplier provided materials.
- Drives continuous improvement with procedures, 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.
- Support the suppliers to ensure that products and processes comply with the relevant requirement.
- Support Quality Management Team in establishing, implementing, and maintaining the quality management system for ISO 9001:2015.
- Assists in the development of procedures & processes in compliance with ISO & other external requirements
- Travel is required – approximately 10-20% depending on status of suppliers and supplier issues.
- Thorough understanding of ISO/QSRs and the ability to apply the knowledge to the business to ensure compliance to the regulations.
- Aware of and comply with TFS and associated Quality Manuals, regulatory requirements and most current world class best practices for the effective management and continuous improvement of supplier quality.
- Participate in PPI (Practical Process Improvement) and projects to support achievement of business metrics to drive improvement to the quality of our products and processes
- B.S. Engineering (Mechanical or Optical)
- Minimum 5 years’ experience in Supplier Quality and Quality Management.
- Ability to focus on continual improvement practices using causal analysis tools to drive corrective and preventive actions.
- Must be able to read and interpret engineering drawings.
- Software Validation Experience preferred
- Electro Mechanical Test Development Experience required
- ISO auditor training and certification
- Lean Six Sigma Green or Black Belt certified preferred.
- Effective problem solving, root cause analytical skills to lead and influence others to drive change (cross-functionally and globally)
- ASQ Certified Quality Engineer preferred
- Extensive ISO9001:2015 experience / auditor or lead auditor trained
- Detail oriented and has the ability to lead multiple projects and activities assigned.
This position does not have relocation assistance.
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