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Quality Engineer

Linea Resourcing Ltd
Posted a month ago, valid for 20 days
Location

Cardiff, South Glamorgan CF24 0TB, Wales

Salary

£38,000 - £10 per annum

Contract type

Full Time

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Sonic Summary

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  • The position is for a Quality Systems Engineer with hybrid working options available at a technology development and manufacturing company.
  • Candidates should have experience managing Quality Management Systems (QMS) in medical device or pharmaceutical settings, including CAPA activities.
  • The role involves managing CAPA activities, conducting audits, and advising teams on regulatory requirements.
  • A competitive salary of £38,000 plus a 10% bonus and extensive benefits are offered.
  • The ideal candidate should have knowledge of ISO 13485, MDD, and FDA regulations, along with excellent communication skills.

QUALITY SYSTEMS ENGINEER - HYBRID WORKING AVAILABLE 
Opportunity for an experienced Quality Systems Engineer to join an established technology development and manufacturing business. As Quality Systems Engineer your activities will contribute to the overall business performance, compliance and quality of products. The business offers hybrid working, competitive salary, bonus and extensive benefits 
What you’ll be doing:
•    Manage CAPA activities and associated reporting
•    Conduct and support internal and external audits 
•    Manage QMS and relevant quality documentation 
•    Advise engineering, production and design teams on relevant regulatory requirements and standards
•    Provide internal guidance and training  relating to QMS documentation and processes
•    Develop new and improve existing QMS documentation and processes 
What you will bring to the role:
•    Previous experience managing QMS systems in a medical device or pharmaceutical setting including CAPA, NCRs, ECNs, ECRs etc 
•    Ideally detailed knowledge of ISO 13485, MDD and FDA regulations 
•    Experience performing internal audits and hosting external audits 
•    Excellent report writing and communication skills 
 

Salary: £38,000 + 10% Bonus + Benefits 

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