Quality Systems Engineer
3 days ago
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).
- 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).
- Adhere to the standards of behaviours, policies and procedures as laid out in the employee handbook.
- All other essential duties as directed.
Education/Qualifications
- Minimum A level or equivalent in a Science/Engineering/Quality orientated qualification
Behaviours/Skills/Experience
- Minimum of 3 years’ experience working in a QA/QS environment within the medical device or pharmaceutical industry.
- Knowledge of ISO13485 and Medical Device Directive MDD 93/42/EEC/Medical Device Regulation (EU) 2017/745
- Knowledge of FDA QSR Part 820
- Computer literate to include MS Word and 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.
- Good record/documentation skills.
- Works with integrity, customer focus, accountability and teamwork.
Benefits
- Generous Pension scheme
- Bonus
- Life Assurance
- Private Health Insurance
- 33 days holiday (including bank holidays)
- Retail Discounts/Cycle to Work scheme
- Hybrid Working (role dependant)
- Employee Assistance Programme
What you should know about us:
ATL Technology is a fast-growing provider of outsourced design, development and manufacturing services to the medical device market, and its UK site (GML Medical Ltd - an ATL Technology owned Company) is based in St Mellons, Cardiff, UK.
We believe there is a better way to bring medical devices to market. 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.
ATL has operations in the UK, China, Costa Rica, Taiwan, UT-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 basic/standard/enhanced 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
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