Quality Systems Engineer

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 regulationsProvide 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 qualificationMinimum 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/EECKnowledge of FDA QSR Part 820Computer literate to include MS Word, Excel and MRPKnowledge of GMP and auditsAbility 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.We offer:Hybrid WorkingBonus SchemeGenerous Pension SchemeFree Life AssurancePrivate Medical Insurance25 days Annual Leave (plus bank holidays)Employee Assistance ProgrammeAbout ATL TechnologyATL 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 were growing!Our Values are:Customer Centric: We create a positive customer experience by utilising our expertise through development and throughout the product lifecycle.Humility: We seek to gain further knowledge to promote mutual growth and understandingAccountability: We commit to the success and well-being of our customers and employees by being accountable for our words and actionsTransparency: We build trusting relationships with our customers and employees by being open and honestSolutions Driven: We work as a team with our customers to achieve results.Other informationYou 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 (An ATL Technology Company), 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 (an ATL Technology Company) is an equal opportunity employer.JBRP1_UKTJ