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Job ID :
52884BR
Location :
United Kingdom - Runcorn
:
Job Description
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and 50,000 employees in 50 countries. 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 and increase laboratory productivity. Our four premier brands - Life Technologies, Thermo Scientific, Fisher Scientific and Unity Lab Services - offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support.

Job Title: Quality Assurance Manager
Reports To: Quality Director
Group/Division: Specialty Diagnostics Group/Anatomical Pathology Division
Career Band: 7
Job Track: Management
Direct reports: 7
Position Location: Runcorn, UK

Position Summary
This site based senior Quality Assurance Manager position will be responsible for driving improvement throughout the site in products and processes, to set up and maintain appropriate quality policies, and to drive customer allegiance and productivity.

Key Responsibilities
  • Drive reduction of customer complaints using solid investigation methodologies and root cause analysis expertise.
  • Establish and monitor performance metrics, champion quality and customer focused initiatives.
  • Utilise in-house and externally obtained data to improve product robustness and reliability
  • Manage and continually improve all elements of the Quality Management System (QMS) including the following processes:
    • Customer Complaint Handling
    • Corrective and Preventive Action
    • Document Control Change Management
    • Supplier Management
    • Acceptance Activities including Incoming Inspection, In process, and Finished Product inspections, Device History Records, Non-Conforming Records, and the Quality Hold process
    • Internal Audits
  • Lead problem solving activities and implementation of permanent fix solutions
  • Utilising key process indicators (KPI’s), promote and initiate PPI initiatives that drive change within the business that result in cost effectiveness and/or revenue enablement. Manage the KPI assimilation/reporting process, drive initiatives that will result in improvement of the APD key drivers.
  • Act as Quality Management Representative for the site
  • Build cross functional team collaborative culture
  • Track and monitor key performance indicators, create summary reports for the site metrics, and promote improvements based on data driven decisions
  • Provide training to the organization regarding ISO13485 requirements
  • Coordinate QA improvement activities with product management, software development, test and operational support teams.
  • Participate in Practical Process Improvement (PPI) Steering Committee
  • Lead and participate on Practical Process Improvement teams
  • Support sourcing (including LCR) initiatives assisting with vendor management and selection. Also provide resources to verify first articles ensuring appropriate design transfer to suppliers.
  • Knowledge of new product introduction practices and ability to support NPD with review of testing protocols to ensure necessary verification and validation of the product and product modules.

Minimum Requirements/Qualifications:
  • Bachelor’s degree or equivalent
  • Proven Quality experience in a manufacturing environment preferably in medical devices of at least 5 years
  • Knowledge of CAPA and understanding of risk application preferably within a medical devices environment
  • Problem solving and root cause analysis expertise
  • Member of the IQA or similar organization (including a quality qualification) preferred
  • Experience with budgets and cost tracking
  • Quality Systems Regulations experience, knowledge of ISO13485
  • Displays Role Model Leadership Skills
  • Supervisor/Management experience required, developing people and self
  • Effective and open communication and attention to detail
  • Must demonstrate strong organizational skills
  • Strong team player and leader with the ability to work with other functional leaders and build strong relationships
  • Working knowledge of international regulation (with respect to instrumentation).
  • Working knowledge of EC regulations e.g. EMC, Low Voltage, IVD Directives preferred
  • Solid understanding of the sales, marketing and software development processes
  • Ability to handle critical timelines in a multi-task environment
  • Proficient in MS applications (Excel, Word, Outlook)
  • ISO13485 Lead Auditor Certification preferred
  • Demonstrated experience as Six Sigma Black Belt or with other continual improvement methodologies is preferred
  • Must be available to travel up to 5% of the time

Non-Negotiable Hiring Criteria:
  • Bachelor’s degree or equivalent or higher in engineering/science subject
  • Analytical problem solving skills required
  • Supervisor experience required
  • Experience in a manufacturing environment
  • Excellent written and oral communication skills



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