Manufacturing Quality Specialist

2 days ago


Oxford, Oxfordshire, United Kingdom Skills Alliance Full time

Company Overview

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Skills Alliance is a world-leading medical technology company dedicated to developing innovative solutions. We are committed to improving patient outcomes through cutting-edge products and services.

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Job Description

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We are seeking a highly motivated Manufacturing Quality Specialist to join our team as part of our global expansion. This is an excellent opportunity to work in an innovative, fast-paced global medical device organisation.

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The successful candidate will be responsible for supporting the day-to-day activities within manufacturing and performing product release testing of medical devices. Key responsibilities include:

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  • Performing and documenting in-process inspection and testing of assemblies and sub-assemblies and finished products.">
  • Maintaining Good Document Practice/Good Manufacturing Practice (GDP/GMP) compliance within the manufacturing QC areas.">
  • Supporting initiatives to deliver measurable performance improvements.">
  • Supporting completion of area-related NC, Investigations, and exception documents for product and processes that are non-conforming related to manufacturing.">
  • Performing weekly/monthly checks of the manufacturing areas – GALA (General Area Line Assessments) walks.">
  • Performing statistical trending analysis of GALA walk rounds/NC raised during manufacturing or final batch release and Service Centre.">
  • Ensuring that all work instructions, SOPs, and test specs that make up part of the BOM/DHR files are current and correct.">
  • Acting as Subject Matter Expert for the area of expertise by maintaining knowledge of relevant procedures and specifications.">
  • Supporting and completing any other work-related tasks set by their manager.">
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Required Skills and Qualifications

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To be successful in this role, you will require:

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  • Bachelor's degree within an engineering discipline or equivalent.">
  • 5 years' experience of working in Manufacturing Quality for medical devices.">
  • Working knowledge of GDP/GMP requirements.">
  • Strong ability to create and write SOPs and work instructions/specifications.">
  • Understanding of inspection criteria, use of drawings/specifications.">
  • Worked in manufacturing for medical devices.">
  • Knowledge of SAP (Desirable).">
  • Knowledge of Master Control or other eQMS.">
  • Understanding of using basic measurement tools (e.g., calipers/jigs and Gauges).">
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Benefits

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This role offers a competitive salary range of £40,000 - £55,000 per annum, depending on experience. You will also have access to a comprehensive benefits package, including health insurance, pension scheme, and annual leave.

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Others

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Please note that this job description may be subject to change based on business needs.



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