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Gyrus Medical Ltd An ATL Technology Company
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 comp
Job Source: Gyrus Medical Ltd An ATL Technology CompanyReed
Cardiff
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Job Source: Acorn by SynergieCardiff
Quality Systems Specialist Job Type: Full-time
Location: Cardiff
Salary: Up to 38,000
We are seeking a Quality Systems Engineer to support the management and improvement of quality systems processes for our client based in Cardiff. They are looking for someone with a minimum of 3 years’ experience in a QA/QS environment, ideally within the medical device or pharmaceutical industry.
Day to Day of the role:
Implement and monitor policies and procedures to ensure compliance with regulatory bodies in areas such as CAPA, Complaint, Post Market Surveillance, and NCR.
Provide advice on established procedures and regulatory requirements including ISO13485, MDD 93/42/EEC, Medical Device Regulation (EU) 2017/745, and 21 CFR Part 820.
Offer effective solutions to design and manufacturing teams to ensure products meet regulatory standards.
Generate reports for management to monitor system performance.
Review and authorise Quality Management System documentation and processes for compliance.
Identify and implement changes to the Quality System to increase efficiency while maintaining compliance.
Conduct training to maintain company-wide awareness of Quality System requirements.
Perform internal and inter-company Quality System Audits.
Work in accordance with Company Quality Standards, GDP, and GMP.
Deputise for the Senior Quality Systems Engineer as required.
Required Skills & Qualifications: A level or equivalent in a Science/Engineering/Quality orientated qualification.
Minimum of 3 years’ experience in a QA/QS environment within the medical device or pharmaceutical industry.
Knowledge of ISO13485:2003, MDD 93/42/EEC, and FDA QSR Part 820.
Proficient in MS Word, Excel, and MRP systems.
Familiarity with GMP and audit processes.
Ability to work independently with minimal supervision.
Excellent interpersonal skills and the ability to communicate effectively in English, both written and orally.
Strong record/documentation skills.
Demonstrates integrity, customer focus, accountability, and teamwork.
Benefits: 25 days annual leave plus bank holidays
10% annual bonus
non-contributory 10% pension scheme
To apply for the Quality Systems Engineer position, please click the link below.
Email Alert for Quality Systems Specialist jobs in Cardiff
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