Quality Systems Engineer, Cardiff

We are looking for a Quality Systems Engineer to provide support to 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 applicant will:

• Implement and monitor established policies and procedures to ensure compliance with necessary regulatory bodies in the areas of: Corrective and Preventive Action (CAPA), Complaint, Post Market Surveillance and Non-conformance Report (NCR).
• Provision of advice according to established procedures relating to CAPA, Complaint, Post Market Surveillance and NCR and against the external requirements of the relevant regulatory authority (ISO13485, Medical Device Directive MDD 93/42/EEC/Medical Device Regulation (EU) 2017/745 and 21 CFR Part 820 and local quality standards.
• 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.
• 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.
• Support and perform training throughout the company to maintain awareness of the Quality System requirements.
• Support and conduct internal and inter-company Quality System Audits in line with local and group objectives.
• Work in accordance with Company Quality Standards, procedures and processes and comply with the requirements of Good Documentation Practice (GDP) and Good Manufacturing Practice (GMP).
• Deputise for Senior Quality Systems Engineer when required, to ensure progression of departmental commitments.

We are looking for someone who has:

• Minimum A level or equivalent in a Science/Engineering/Quality orientated qualification.
• Minimum of 3 years' experience working in a QA/QS environment, preferably within the medical device or pharmaceutical industry.
• Knowledge of ISO13485:2003 and Medical Device Directive MDD 93/42/EEC.
• Knowledge of FDA QSR Part 820.
• Computer literate to include MS Word, Excel and MRP.
• Knowledge of GMP and audits.
• 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.
• Works with integrity, customer focus, accountability and teamwork.

We offer:

• Hybrid Working.
• Bonus Scheme.
• Free Life Assurance.
• Private Medical Insurance.
• Employee Assistance Programme.

About ATL Technology

ATL Technology 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.

Gyrus Medical Ltd (An ATL Technology Company) is an equal opportunity employer.