Quality Systems Engineer

• 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.

• 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.

• 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.