Medical Device Inspector
3 days ago
Job Title: Manufacturing Quality Specialist
">Location: Oxford, UK
">We are seeking a skilled Manufacturing Quality Specialist to join our team in Oxford, UK. As a key member of our quality team, you will play a crucial role in ensuring the highest standards of quality in our manufacturing processes.
">The ideal candidate will have a strong background in manufacturing quality, with experience working in a similar role for a medical device company. You will be responsible for performing inspections, tests, and audits to ensure compliance with GDP/GMP regulations.
">You will work closely with our production team to identify areas for improvement and implement changes to optimize our manufacturing processes. Your strong communication skills and attention to detail will enable you to build effective relationships with colleagues and stakeholders.
">This is an exciting opportunity to work for a world-leading medical technology company and contribute to the development of innovative solutions. If you are a motivated and organized individual with a passion for quality, we encourage you to apply for this role.
">Key Responsibilities:
">- ">
- 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.">
Requirements:
">- ">
- 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).">
What We Offer:
">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.
">How to Apply:
">Please submit your application, including your CV and cover letter, to [insert contact details].
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