Senior Quality Systems Engineer
1 month ago
We are looking for a Senior Quality Systems Engineer to 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 applicant 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 Assistant
- 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 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.
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.
Job Posted by ApplicantPro
-
Senior Quality Systems Engineer
3 weeks ago
Cardiff, Cardiff, United Kingdom ATL Technology Full timeJob 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
4 weeks ago
Cardiff, Cardiff, United Kingdom ATL Technology Full timeJob 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
4 weeks ago
Cardiff, Cardiff, United Kingdom ATL Technology Full timeJob 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
4 weeks ago
Cardiff, Cardiff, United Kingdom Reed Full timeReed 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
4 weeks ago
Cardiff, Cardiff, United Kingdom Gyrus Medical Limited Full timeJob 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 timeJob 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 Reed Full timeReed 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
3 weeks ago
Cardiff, Cardiff, United Kingdom ATL Technology Full timeJob 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...
-
Senior Embedded Systems Engineer
2 weeks ago
Cardiff, Cardiff, United Kingdom Panasonic Automotive Systems Europe Full timeJob DescriptionAt Panasonic Automotive Systems Europe, we are seeking an experienced Senior Embedded Systems Engineer to join our team.The ideal candidate will possess a degree-level qualification in a System or Software Engineering discipline, along with 3 years of relevant industry experience or at least 5 years in a similar role.Key...
-
Senior Quality Systems Engineer
4 weeks ago
Cardiff, Cardiff, United Kingdom ATL Technology Full timeJob DescriptionATL Technology is seeking a highly skilled Senior Quality Systems Engineer to join our team in Cardiff, UK. As a key member of our Quality team, you will be responsible for ensuring the management and improvement of quality systems processes to ensure both EU and US regulatory compliance to relevant company standards and Good Manufacturing...
-
Senior Quality Systems Engineer
3 weeks ago
Cardiff, Cardiff, United Kingdom ATL Technology Full timeJob SummaryWe 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 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).Key...
-
Senior Quality Systems Engineer
3 weeks ago
Cardiff, Cardiff, United Kingdom Gyrus Medical Limited Full timeWe 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 guarantee both EU and US regulatory compliance to relevant company standards and Good Manufacturing Practice (GMP).The...
-
Senior Quality Systems Engineer
4 weeks ago
Cardiff, Cardiff, United Kingdom Gyrus Medical Limited Full timeWe 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...
-
Senior Quality Systems Engineer
3 weeks ago
Cardiff, Cardiff, United Kingdom Gyrus Medical Limited Full timeWe are seeking a highly skilled Senior Quality Systems Engineer to join our team at Gyrus Medical Ltd. As a key member of our quality assurance department, 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...
-
Senior Quality Systems Engineer
3 weeks ago
Cardiff, Cardiff, United Kingdom Gyrus Medical Limited Full timeWe 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...
-
Quality Systems Engineer
3 weeks ago
Cardiff, Cardiff, United Kingdom Gyrus Medical Limited Full timeWe are seeking a highly skilled Quality Systems Engineer to join our team at Gyrus Medical Limited. As a Quality Systems Engineer, you will be responsible for providing 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...
-
Quality Systems Engineer
4 weeks ago
Cardiff, Cardiff, United Kingdom Gyrus Medical Limited Full timeWe are seeking 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...
-
Senior Engineering Leader
4 weeks ago
Cardiff, Cardiff, United Kingdom BAE Systems Full timeChief Engineer - ATMLocation:GlascoedSalary: Circa £75,000 depending on skills and experienceAs a Chief Engineer, you will lead a multi-disciplined engineering team to deliver against IDT outcomes whilst being responsible and accountable for the integrity of product and services.Key Responsibilities:Delegating of Engineering Authority (EA) for the IDT...
-
Senior Quality Systems Engineer
4 weeks ago
Cardiff, Cardiff, United Kingdom Reed Full timeReed Engineering is currently partnered with a leading company in the medical device industry. 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...
-
Quality Systems Engineer
4 weeks ago
Cardiff, Cardiff, United Kingdom Gyrus Medical Limited Full timeJob Title: Quality Systems EngineerWe are seeking a highly skilled Quality Systems Engineer to join our team at Gyrus Medical Ltd. As a Quality Systems Engineer, you will play a critical role in ensuring the quality and compliance of our medical devices.Key Responsibilities:Implement and monitor quality systems processes to ensure compliance with EU and US...
