Quality Engineer Automotive

3 weeks ago


Cardiff, United Kingdom Reed Full time

Quality Systems Engineer
Job Type: Full-time
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.
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.
Proficient in MS Word, Excel, and MRP systems.
Excellent interpersonal skills and the ability to communicate effectively in English, both written and orally.
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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