Xiros is a multi-award winning medical devices company specialising in sports medicine. Our mission is to create the highest quality, innovative medical devices and we are committed to putting people first and developing them.
The Quality Systems team are now looking to recruit an additional Senior Quality Associate, with a specific focus on conducting CAPA investigations into engineering issues. The role will involve problem solving and root cause analysis for quality issues using tools such as 8D Problem Solving, conducting investigations into complaints and writing reports and recommendations.
The successful candidate will have a degree in engineering, previous experience of working in a quality department to a recognised quality management system and experience of CAPA and root cause analysis.
37.5 hours per week (flexible working hours)
Quality Systems Manager
- Conduct CAPA investigations and identify appropriate corrective actions with a specific focus on engineering issues.
- Facilitating problem solving and root cause analysis for quality issues using tools such as 8D Problem Solving.
- Identify appropriate technical colleagues to take part in review groups and chair groups in relation to investigations.
- Conduct investigations into complaints with a specific focus on engineering issues and write reports and recommendations. Liaise with complainants as required.
- Data collection, analysis and trending with the aim of reducing non- conformities and raising any Corrective Action or preventative action reports required.
- Reviewing inspection data and trends established by Quality Control and working with Quality Control and Manufacturing with a view to identifying root cause of issues and determining improvements.
- Undertake any other duties as may be requested by the Quality Systems Manager or Compliance Director.
Essential Experience, Knowledge and Qualifications:
- Degree in engineering.
- Experience of working in a Quality environment, preferably within the medical device industry, but other related industries would be considered.
- Experience of CAPA and root cause analysis.
- Working to a recognised QMS; preferably ISO 13485, but those with experience of ISO 9001 will also be considered.
Desirable Experience, Knowledge and Qualifications:
- Experience/knowledge of orthopaedic instruments and implants