Address
Form of work
Salary- 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.
