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 effective management and improvement of our quality systems processes to meet EU and US regulatory compliance requirements.

Key Responsibilities:
  • Deputise for the Head of Quality & Regulatory as required, ensuring the progression of departmental commitments.
  • Supervise QS Engineers and QS Technical Assistants, providing guidance and support to ensure the successful implementation of quality systems processes.
  • Support the development and maintenance of policies and procedures to ensure compliance with relevant regulatory bodies, including CAPA, Complaints, Post Market Surveillance, NCR, Document Control, Incoming Inspection, and Product Release.
  • Participate in the interpretation of EU and US regulatory requirements to produce effective working policies and procedures.
  • Provide expert advice to design and manufacturing teams on established procedures to ensure products meet regulatory requirements.
  • Manage and conduct internal and inter-company quality system audits, ensuring the audit process lifecycle is completed efficiently.
  • Ensure the timely progression of improvement activities resulting from audit findings.
  • Support second and third-party audits of ATL-UK.
  • Analyse data, including statistical techniques, to provide reports to management, enabling them to monitor system performance.
  • Review and authorise documentation and processes in the Quality Management System to ensure compliance with established quality procedures and applicable regulations.
  • Identify and collaborate in the implementation of changes to the Quality System to increase efficiency and/or effectivity while ensuring compliance with applicable regulations.
  • Supervise and deputise for other team members as required.
  • Support and perform training throughout the company to maintain awareness of the Quality System requirements.
Requirements:
  • Diploma-level Science/Engineering/Quality-oriented qualification.
  • Lead Auditor qualification (ISO 9000 series-based quality system essential, ISO 13485 preferred).
  • Minimum of 3 years' experience working in a QA/QS environment within the medical device or pharmaceutical industry.
  • Knowledge of ISO 13485, Medical Device Directive MDD 93/42/EEC, Regulation (EU) 2017/745, and FDA QSR Part 820.
  • Good analytical skills and experience of statistical techniques.
  • Computer literate, including MS Word and Excel, and MRP.
  • GMP and audit qualifications.
  • Supervisory experience.
  • Ability to work with minimal supervision and use initiative.
  • Good interpersonal skills and the ability to communicate well in English, both written and orally.
  • Good record/documentation skills.
  • Works with integrity, customer focus, accountability, and teamwork.
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.

  • Senior Quality Systems Engineer

    4 weeks ago

    Cardiff, Cardiff, United Kingdom ATL Technology Full time

    Job Title: Senior Quality Systems EngineerWe are seeking a highly skilled Senior Quality Systems Engineer to join our team at ATL Technology. As a key member of our quality team, you will be responsible for ensuring the effective management and improvement of our quality systems processes to meet EU and US regulatory compliance requirements.Key...

  • Senior Quality Systems Engineer

    4 weeks ago

    Cardiff, Cardiff, United Kingdom ATL Technology Full time

    Job Title: Senior Quality Systems EngineerWe are seeking a highly skilled Senior Quality Systems Engineer to join our team at ATL Technology. As a key member of our quality team, you will be responsible for ensuring the effective management and improvement of our quality systems processes to meet EU and US regulatory compliance requirements.Key...

  • Senior Quality Systems Engineer

    4 weeks ago

    Cardiff, Cardiff, United Kingdom Gyrus Medical Limited Full time

    Job Title: Senior Quality Systems EngineerWe 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...

  • Senior Quality Systems Engineer

    4 weeks ago

    Cardiff, Cardiff, United Kingdom Gyrus Medical Limited Full time

    Job Title: Senior Quality Systems EngineerWe 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...

  • Senior Quality Systems Engineer

    4 weeks ago

    Cardiff, Cardiff, United Kingdom ATL Technology Full time

    Job Title: Senior Quality Systems EngineerATL Technology is seeking a highly skilled Senior Quality Systems Engineer to join our team. As a key member of our quality team, you will be responsible for ensuring the quality of our medical devices and ensuring compliance with regulatory requirements.Key Responsibilities:Manage and improve quality systems...

  • Senior Quality Systems Engineer

    4 weeks ago

    Cardiff, Cardiff, United Kingdom ATL Technology Full time

    Job Title: Senior Quality Systems EngineerATL Technology is seeking a highly skilled Senior Quality Systems Engineer to join our team. As a key member of our quality team, you will be responsible for ensuring the quality of our medical devices and ensuring compliance with regulatory requirements.Key Responsibilities:Manage and improve quality systems...

  • Senior Quality Systems Engineer

    4 weeks ago

    Cardiff, Cardiff, United Kingdom Gyrus Medical Limited Full time

    Job Title: Senior Quality Systems EngineerWe 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...

  • Senior Quality Systems Engineer

    4 weeks ago

    Cardiff, Cardiff, United Kingdom Gyrus Medical Limited Full time

    Job Title: Senior Quality Systems EngineerWe 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...

  • Senior Quality Systems Engineer

    3 weeks ago

    Cardiff, Cardiff, United Kingdom ATL Technology Full time

    Job Title: Senior Quality Systems EngineerWe are seeking a highly skilled Senior Quality Systems Engineer to join our team at ATL Technology. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality and compliance in our medical device manufacturing processes.Key Responsibilities:Develop and implement quality...

  • Senior Quality Systems Engineer

    3 weeks ago

    Cardiff, Cardiff, United Kingdom ATL Technology Full time

    Job Title: Senior Quality Systems EngineerWe are seeking a highly skilled Senior Quality Systems Engineer to join our team at ATL Technology. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality and compliance in our medical device manufacturing processes.Key Responsibilities:Develop and implement quality...

  • Senior Quality Systems Engineer

    2 weeks ago

    Cardiff, Cardiff, United Kingdom ATL Technology Full time

    Job DescriptionJob Title: Senior Quality Systems EngineerJob Summary: We are seeking a highly skilled Senior Quality Systems Engineer to join our team at ATL Technology. The successful candidate will be responsible for managing and improving quality systems processes to ensure EU and US regulatory compliance.Key Responsibilities:Regulatory Compliance: Ensure...

  • Senior Quality Systems Engineer

    3 weeks ago

    Cardiff, Cardiff, United Kingdom Reed Full time

    Reed Engineering is seeking a Senior Quality Systems Engineer to join their team. This pivotal role focuses on managing and enhancing quality systems processes to ensure compliance with both EU and US regulatory standards and Good Manufacturing Practice (GMP). Responsibilities: * Enforce and support policies and procedures to ensure compliance with...

  • Senior Quality Systems Engineer

    1 month ago

    Cardiff, Cardiff, United Kingdom Gyrus Medical Limited Full time

    Job Title: Senior Quality Systems EngineerWe 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 ensure compliance with EU and US regulatory requirements.Key...

  • Senior Quality Systems Engineer

    4 weeks ago

    Cardiff, Cardiff, United Kingdom Gyrus Medical Limited Full time

    Job Title: Senior Quality Systems EngineerWe 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 effective management and improvement of our quality systems processes to meet EU and US regulatory compliance requirements.Key...

  • Senior Quality Systems Engineer

    4 weeks ago

    Cardiff, Cardiff, United Kingdom Gyrus Medical Limited Full time

    Job Title: Senior Quality Systems EngineerWe 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 ensure compliance with EU and US regulatory requirements.Key...

  • Senior Quality Systems Engineer

    4 weeks ago

    Cardiff, Cardiff, United Kingdom Gyrus Medical Limited Full time

    Job Title: Senior Quality Systems EngineerWe 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 effective management and improvement of our quality systems processes to meet EU and US regulatory compliance requirements.Key...

  • Senior Quality Systems Engineer

    3 weeks ago

    Cardiff, Cardiff, United Kingdom Gyrus Medical Limited Full time

    Job Title: Senior Quality Systems EngineerWe 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 ensure compliance with EU and US regulatory requirements.Key...

  • Senior Quality Systems Engineer

    4 weeks ago

    Cardiff, Cardiff, United Kingdom Gyrus Medical Limited Full time

    Job Title: Senior Quality Systems EngineerWe 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 ensure compliance with EU and US regulatory requirements.Key...

  • Senior Quality Systems Engineer

    3 weeks ago

    Cardiff, Cardiff, United Kingdom Reed Full time

    Reed Engineering is seeking a highly skilled Senior Quality Systems Engineer to join their team. This pivotal role focuses on managing and enhancing quality systems processes to ensure compliance with both EU and US regulatory standards and Good Manufacturing Practice (GMP).Key Responsibilities:Enforce and support policies and procedures to ensure compliance...

  • Senior Quality Systems Engineer

    2 weeks ago

    Cardiff, Cardiff, United Kingdom ATL Technology Full time

    Job DescriptionTo ensure the highest quality standards in the medical device industry, we are seeking a highly skilled Senior Quality Systems Engineer to join our team at ATL Technology.This role is responsible for the management and improvement of quality systems processes to ensure both EU and US regulatory compliance to relevant company standards and Good...