Quality Inspector

Selexa Life Sciences Ltd are delighted to partner with a leading Medical Device start up in the search for a Quality Inspector to join their Quality function. You will be responsible for ensuring quality assurance and compliance of products, materials, processes and documentation relating to medical device manufacture, as well as goods-in inspection, process inspection and final product testing.

Key Responsibilities:

Manufacturing Quality Assurance:

• Inspecting materials, equipment, processes and products – goods in inspection, process QC checks, final functional testing
  
  
• Testing the products and analysing the results
  
  
• Reviewing the batch records, ensuring error-free manufacturing and batch release
  
  
• Ensure Regulatory compliance of facility and services
  
  
• Creating & enhancing tooling descriptions, perform calibrations, and ensuring appropriate and correct documentation updates
  
  Quality and Regulatory:
  
  
• Contribute to maintaining QMS and related documentation including supplier records, audits, purchase and manufacturing batch information, and CAPAs
  
  
• Support audits and inspections by NB, competent authorities and FDA
  
  
• Participate in internal audits
  
  
• Support investigations, analysis and closure of relevant NCRs
  
  Engineering:
  
  
• Provide technical support, resolve quality issues with suppliers, customers or auditors
  
  
• Supporting Engineering, R&D and QARA functions on required projects
  
  Qualifications & Experience:
  
  
• Strong understanding of quality assurance and manufacturing processes
  
  
• Experience in NCRs and CAPAs
  
  
• Experience in QA/QC in terms of inspection and measurement, visual inspection et
  
  
• Working knowledge within ISO13485 environment
  
  
• Ideally qualified to apprenticeship or HNC/HND level in Electromechanical Engineering
  
  
• Experience of electromechanical products and assemblies within medical devices
  
  
• Experience with oscilloscopes and multimeters, and digital calipers
  
  
• Knowledge of, and worked to the requirements of industry standards e.g. IPC-A-600,
  
  IPC-A-610 and quality management systems such as ISO13485, AS9100 or ISO9001