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.
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.
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