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Job ID :
Location :
United Kingdom - Runcorn
Job Description

Company Information

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. 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, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.

Job Description

Job Title: Supplier Quality Engineer
Reports To: QA Manager
Group/Division: Anatomical Pathology Division
Career Band: 6
Job Track: Professional
Position Location: Runcorn, UK

Key Responsibilities:
  • Supporting supplier selection and approval by performing quality & compliance assessments/audits of proposed new suppliers and ongoing monitoring of existing suppliers.
  • Developing systems, metrics and reports for ongoing supplier performance monitoring, providing input to periodic Supplier Performance Monitoring meetings and Management Reviews.
  • Acting as Subject Matter Expert (SME) for QA supplier controls, ensuring policies, procedures and practices are in compliance with global quality & regulatory requirements and meet the needs of our customers & Quality Policy.
  • Working with QA, Engineering and Sourcing as required, this role leads the failure investigation with suppliers following the rejection of supplied components or customer complaints arising from nonconforming supplied components. Developing and agreeing supplier CAPA’s resulting from such investigations.
  • Using established quality improvements & lean tools, this role supports quality improvement of suppliers and their supplied components.
  • Working with QA, Engineering and Sourcing as required, this role coordinates the preparation of quality test/inspection plans (including design verification & validation) for proposed new components and/or existing components from a new supplier.
  • Leading the initial QA assessment of supplier notified changes, ensuring the prompt and effective evaluation of the change by all key functions.
  • This role actively participates in joint supplier strategic performance reviews with other Thermo Fisher site/Diversion representatives, ensuring the timely input of required performance data/metrics from APD.
  • Provides QA support for sourcing projects helping to achieve site, Business Unit, Division and company goals.
  • Establishing effective working links with other Thermo Fisher Supplier Quality & Sourcing professionals in order to improve processes and supplier quality.
  • Work with the Thermo Fisher China team to ensure effective communication of supplier related issues, quality improvement activities and provide support to product transfer/sourcing projects.
  • Responsible for performing tasks to support the quality system and quality policy as directed by QA/RA management.

Minimum Requirements/Qualifications:
  • A degree in an Engineering or Scientific discipline.
  • Experience of working within a QA and/or Sourcing Team preferred.
  • Experience of working with Medical Device/IVD regulated products.
  • Experience & recognized training in internal & supplier auditing, preferably as a lead auditor.
  • Knowledge of ISO13485/ FDA QSR Part 820 requirements with particular focus of supplier controls and supplier performance management, CAPA & management review.
  • Knowledge of quality investigation and improvement tools, (8D, cause & effect, FMEA, 5Whys ect.)
  • Knowledge of statistical techniques (Gage R&R, Acceptance Sampling, Process Capability, Statistical Process Control)
  • Basic Knowledge of lean methods (5S, Lean Six Sigma, Kaizen)
  • Excellent interpersonal and communication skills both written & oral
  • Ability to work in a timeline driven environment
  • Excellent IT skills
  • Working knowledge of foreign languages (such as German & Mandarin) is desirable but not essential.
  • Up to 50% travel (UK, European & International including Far East e.g. China)

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.
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