Senior Quality Systems Engineer

4 weeks ago

Cardiff, Cardiff, United Kingdom Gyrus Medical Limited Full time

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 the management and improvement of quality systems processes to ensure both EU and US regulatory compliance to relevant company standards and Good Manufacturing Practice (GMP).


The successful candidate will:

  • Deputise for the Head of Quality & Regulatory when required, to ensure progression of departmental commitments.
  • Have supervisory responsibility for QS Engineers and QS Technical Assistants.
  • Support established policies and procedures to ensure compliance with necessary regulatory bodies in the areas of: Corrective and Preventive Action (CAPA), Complaints, Post Market Surveillance, Non-conformance Report (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 effective solutions/advice to design and manufacturing teams on established procedures to ensure products are designed and developed and manufactured according to the requirements of the relevant regulations.
  • Manage and conduct internal and inter-company Quality System Audits with responsibility for the audit process lifecycle.
  • Ensure the timely progression of improvement activities resulting from audit findings.
  • Support second and third party audits of ATL-UK.
  • Analyse data, including the use of statistical techniques, to provide reports to management to enable 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 and alignment with other related documentation.
  • Identify and collaborate in the implementation of changes to the Quality System to increase efficiency and/or effectivity whilst ensuring compliance with applicable regulations.
  • Supervisory / deputising duties for other team members, as required.
  • Support and perform training throughout the company to maintain awareness of the Quality System requirements.
  • Work in accordance with Company Quality Standards, procedures and processes and comply with the requirements of GDP and GMP.

We are looking for someone who has:

  • 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.
  • Good analytical skills and experience of statistical techniques.
  • Computer literate to include MS Word and Excel and MRP.
  • GMP and audit qualifications.
  • Supervisory experience.
  • 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.
  • Good record/documentation skills.
  • Works with integrity, customer focus, accountability and teamwork.

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.

About Gyrus Medical Ltd


Gyrus Medical Ltd is a fast-growing provider of outsourced design, development and manufacturing services to the medical device market, and its UK site is based in St Mellons, Cardiff.


We believe that there is a better way to bring medical devices to market and we use an engineer-to-engineer approach to develop custom interconnect solutions for medical devices that improve the quality of one's life. It is our mission to be the leading provider of custom engineered solutions for top medical device manufacturers.


Aside from our site in the UK, we also have operations in China, Costa Rica, Taiwan and the USA; plus, remote staff in strategic global locations... and we're growing


Other information


You will be required to provide evidence of your eligibility to work and reside in the UK, in accordance with the requirements of Section 15 of the Immigration, Asylum and Nationality Act 2006. The role that you are applying for may require you to undertake a Disclosure & Barring Service (DBS) check.


At Gyrus Medical Ltd, we have a dedicated in-house recruitment team that cover all areas of the business. As a backup, we have a preferred supplier list (PSL) of vetted suppliers and as such, are unable to accept unsolicited CVs from recruitment agencies or search firms outside of our PSL (which is now closed to new suppliers). Please note that Gyrus or ATL will not be responsible for any fees, charges or terms associated with any such CVs. CVs will only be accepted from approved agencies where terms and conditions have been agreed and we have instructed them to work on specific positions. Agencies will be contacted by the recruitment team should we wish to engage their services. We do not take sales calls and politely request that you refrain from directly approaching the recruitment team or line managers and remove Gyrus Medical Ltd from your mailing list. Thank you for your understanding.


Gyrus Medical Ltd is an equal opportunity employer.

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