QA Engineer III
Thermo Fisher Scientific
Paisley, United Kingdom
2d ago

Position Objective :

Working as part of the quality engineering team within a fast growing industry, you will support and maintain the Quality Management System consistent with ISO13485 and FDA 21CFR Part 820.

Assure compliance to in-house and / or external specifications and standards. Actively lead the data collection, trend analysis, root cause analysis, robust CAPA implementation bus as well as implement improvements to processes, products and systems.

  • Work closely and collaboratively with Production, Technical and Manufacturing Engineering to resolve quality related issues arising from customer complaints / concerns and internal incidents.
  • Responsible for the facilitation of investigations and resolution of related quality issues ensuring structured root cause analysis and robust CAPA plan implementation.
  • Performs statistical analysis to analyze trends, pro-actively managing any potential issues.
  • Works with manufacturing to investigate emerging trends, conduct robust root cause analysis and lead corrective actions for processes and products.
  • Assures compliance to in-house and / or external specifications to standards, such as GMPs and ISO regulations, and approves disposition for non-conformances on raw materials and finished goods.
  • Leads PPI activities at the site including the facilitation of Kaizen events and supporting the other Quality team members on process improvement activities.
  • Manages the site change control system including process risk assessment in the form of FMEA and HACCP tools.
  • Apply the Agile system for change controls and provide training, support and facilitate the change control process within operations.
  • Supports customer & 3rd party audits.
  • Maintain working knowledge of Regulatory and Quality System requirements (ISO13485 / FDA CFR).
  • May Lead site CAPA system and complaint management process and provides monthly reviews to senior management.
  • Participates on the Internal Quality Audit team.
  • Leads Quality related projects and represents quality as and when required on projects across operations.
  • Represents the site quality systems to customers in face meetings or through written and verbal correspondence.
  • Provide training, support and guidance to other Quality Engineering Staff as and when required.
  • Perform independently without continual direction and exercise considerable latitude in determining technical objectives and solutions to complex problems.
  • May be required to perform other related tasks as required.
  • Education :

    Requires a Bachelors / Masters degree in chemistry, biochemistry, microbiology, engineering or related discipline.

    Experience :

  • Extensive related quality experience and demonstrated working knowledge of compliance, quality and scientific principles.
  • Should be proficient in Six Sigma tools and methodology.

  • Strong oral and written communication skills with a demonstrated ability to work in a cross-functional team environment and to effectively interact with all levels in the company.
  • Effective communication skills and the ability to collaborate with internal and external development team members are essential.

  • Must be a self-starter who can take general concepts and direction and produce desirable results. Also must function effectively and efficiently in a global, multi-site organization
  • Contacts :

    Will liaise extensively with all other departments on matters relating to quality and service in order to uphold the Company’s commitment to Customer satisfaction.

    This involves working with people at all levels within the organisation as well as external customers and regulatory bodies.

    Working Conditions :

    Works in an office environment but may be required to spend some time in manufacturing and the warehouse.

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