Senior Quality Systems Engineer

4 weeks ago


Cardiff, Cardiff, United Kingdom Gyrus Medical Limited Full time
Job Title: Senior Quality Systems Engineer

We are seeking a highly skilled Senior Quality Systems Engineer to join our team at Gyrus Medical Ltd. As a key member of our quality team, you will be responsible for ensuring the management and improvement of quality systems processes to meet EU and US regulatory compliance requirements.

Key Responsibilities:
  • Manage and improve quality systems processes to ensure compliance with EU and US regulatory requirements
  • Deputise for the Head of Quality & Regulatory as required, to ensure progression of departmental commitments
  • Support established policies and procedures to ensure compliance with necessary regulatory bodies
  • Participate in the interpretation of EU and US regulatory requirements to produce effective working policies and procedures
  • Manage and conduct internal and inter-company Quality System Audits
  • Analyse data to provide reports to management to enable them to monitor system performance
  • Review and authorise documentation and processes in the Quality Management System
  • Identify and collaborate in the implementation of changes to the Quality System to increase efficiency and/or effectiveness
  • Support and perform training throughout the company to maintain awareness of the Quality System requirements
Requirements:
  • Diploma level Science/Engineering/Quality orientated qualification
  • Lead Auditor qualification (ISO 9000 series based quality system essential, ISO13485 preferred)
  • Minimum of 3 years' experience working in a QA/QS environment within the medical device or pharmaceutical industry
  • Knowledge of ISO13485, Medical Device Directive MDD 93/42/EEC, Regulation (EU) 2017/745 and FDA QSR Part 820
  • Computer literate to include MS Word and Excel and MRP
  • Ability to work with minimal supervision and use initiative
  • Good inter-personal skills and the ability to communicate well in English both written and orally
What We Offer:
  • Hybrid Working
  • Bonus Scheme
  • Generous Pension Scheme
  • Free Life Assurance
  • Private Medical Insurance
  • 25 days Annual Leave (plus bank holidays)
  • Employee Assistance Programme


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