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Job ID :
52831BR
Location :
United Kingdom - Paisley
:
Job Description

Position Objective:

Establishes and maintains appropriate Quality Systems consistent with ISO13485 and FDA 21CFR Part 820. Assures compliance to in-house and/or external specifications and standards. Actively leads the data collection, trend analysis, investigation and improvements to processes, products and systems.

Essential Functions:

  • Work closely 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.
  • Works with technical support and manufacturing to create and/or modify methods and procedures to ensure that appropriate processes and/or products are developed, tests are conducted and that products, materials, and manufacturing equipment meet required standards.
  • Constantly strive to enhance efficiency in procedures and processes without a compromise in quality. Identify and implement opportunities for improvement across the operational facility.
  • Performs statistical analysis to analyze trends, and works with manufacturing to investigate trends, conduct root cause analysis and lead corrective actions for processes and products.
  • Maintain working knowledge of Regulatory and Quality System requirements (ISO13485/FDA CFR).
  • Utilise the Trackwise system for non conformances, deviations, Corrective and Preventative Actions (CAPA).
  • Participates on the Internal Quality Audit team.
  • 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.
  • Provide training and support to other QA staff as 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 duties as required and/or assigned.

*IND-EMEA
*LI - KP1



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