Senior Quality Assurance Specialist
2 weeks ago
As a Senior Quality Assurance Specialist for the Supply Chain at Thermo Fisher Scientific, you will play a vital role in ensuring the quality of our supplied products and materials. The primary responsibilities of this position include qualifying new suppliers, analyzing and improving supplier performance, implementing corrective actions or quality plans at supplier sites to prevent repeat nonconformances using Quality Tools (FMEA,5M1E, Control Plan etc.), and performing supplier audits.
This role requires collaboration with Procurement, R&D, and Operations teams to effectively work on supply priorities and actions. You will ensure that Supplier Quality function tasks operate according to procedures, multi-functionally coordinate with the Procurement team assigned to support supplied products and materials, review and approve supplier records, including quality agreements, quality plans, change requests, SCARs/CAPAs, verification and validation protocols, and reports.
In addition, you will participate in the Supply Chain Risk Management teams, CAPA Review Board meetings, and other critical decision-making meetings as required to define and assess supplier roles, responsibilities, and effectiveness.
Qualification Requirements- Degree in Engineering, Biological Sciences, or equivalent
- Experience in a Supplier Quality role with Medical instruments/devices
- ISO13485 or/and ISO 9001 internal Auditor certified
- Knowledge of IS0 13485 and 21 CFR Part 820
- Ability to work independently and self-motivated
- Excellent oral and written communication skills
The estimated salary range for this position is between $80,000 to $110,000 per year, depending on qualifications and experience. Additionally, we offer a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, paid time off, and opportunities for professional growth and development.
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