Senior Quality Systems Engineer
- Job Type: Full-time
- Location: Cardiff
- Salary: £40,000 - £45,000
Reed Engineering is currently partnered with a leading company in the medical device industry. This pivotal role focuses on managing and enhancing quality systems processes to ensure compliance with both EU and US regulatory standards and Good Manufacturing Practice (GMP).
Day-to-day Responsibilities:
- Enforce and support policies and procedures to ensure compliance with regulatory bodies including CAPA, Complaints, Post Market Surveillance, NCR, Document Control, Incoming Inspection, and Product Release.
- Interpret EU and US regulatory requirements to develop effective working policies and procedures.
- Advise design and manufacturing teams to ensure products are designed, developed, and manufactured in compliance with relevant regulations.
- Oversee the entire audit process lifecycle, managing and conducting internal and inter-company Quality System Audits.
- Drive improvement activities based on audit findings and support external audits.
- Review and authorise documentation and processes within the Quality Management System, ensuring compliance and alignment with related documentation.
- Implement changes to the Quality System to enhance efficiency and effectiveness while maintaining compliance.
- Provide training on Quality System requirements across the company and perform supervisory duties as needed.
- Ensure adherence to Company Quality Standards, GDP, and GMP.
Required Skills & Qualifications:
- Diploma in Science, Engineering, or a Quality-related field.
- Lead Auditor qualification (ISO 9000 series, ISO13485 preferred).
- At least 3 years' experience in a QA/QS role within the medical device or pharmaceutical industry.
- Proficient in ISO13485, Medical Device Directive MDD 93/42/EEC, Regulation (EU) 2017/745, and FDA QSR Part 820.
- Proficiency in MS Word, Excel, and MRP systems.
- GMP and audit qualifications.
If this is an opportunity you would be interested in, apply below to find out more!