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Quality Assurance Engineer

Reed
Job LocationCardiff
EducationNot Mentioned
Salary£35,000 - £38,000 per annum, inc benefits
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Quality Assurance 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 themedical 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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