Supervisor, QA (Quality Systems Engineer)

Description

How you will make an impact

• Manage the ISO 9001 internal audit programme, including auditor qualification and competency maintenance, and conduct audits in line with the approved schedule
• Liaise with customers regarding regulatory, compliance and technical issues
• Coordinate and lead external audit activites with customers
• Ensure technical files are up to date and in full compliance with IVDR (EU) 2017/746
• Liaise with Certification & Notified Bodies regarding ISO certification issues and CE marking of product
• Liaise with the MHRA and other Competent Authorities regarding regulatory compliance to IVDR
• Manage the customer complaints process, ensuring effective root cause analysis has been carried out and that corrective action plans are produced, are effective and completed within agreed timescales
• Produce customer complaint reports and ensure customer complaint response times comply with company targets
• Train relevant personnel in root cause analysis as required
• Analyse complaint data and monitor trends to highlight further areas of improvement
• Produce monthly complaint KPI reports
• Support the ongoing maintenance and effective operation of electronic quality systems, ensuring systems remain compliant, current, and fit for purpose.
• Provide functional oversight of the Batch Release Team, supporting workload coordination, prioritisation and activities to ensure timely and compliant batch release.

Requirements

Minimum Requirements/Qualifications

• Honours degree in a science or engineering subject
• Fully conversant in Microsoft Word & Excel (especially Pivot tables)
• Six Sigma Green or Black Belt certification preferred
• Previous experience in blow/injection moulding and extrusion would be advantageous
• Formal qualifications in quality e.g. CQI Diploma, A11, A12 or MSc preferred
• Full member or Chartered member status of the Chartered Quality Institute would be advantageous
• Proven experience of successfully managing internal audit programmes
• Lead QMS auditor qualification would be advantageous
• Background or experience working within ISO13485 Quality Management Systems would be advantageous

Non-Negotiable Hiring Criteria

• Proven experience of dealing with Notified Bodies and the MHRA regarding regulatory compliance issues for IVDR
• Formal training, proven experience and success in the use of quality tools such as RCA, 5Y, 8D, C&E, Pareto, Control Charts etc.
• Previous experience in a regulatory or compliance role in the medical device/IVD sector