Under limited supervision and with a solid understanding of science and technology, the Manager will be responsible for the day-to-day operation of the Memphis Quality Team and support the Quality & Regulatory Manager. The Manager will monitor, operate, develop and manage quality improvement initiatives to ensure that systems are safe, effective, appropriate, compliant, current, and adhered to by staff for the Company’s Memphis site.  The role is responsible for the ensuring the effectiveness of the QMS and monitoring compliance associated with CLIA, CAP, State regulations, ISO 9001, ISO 17025 and the QSR.

ESSENTIAL FUNCTIONS:

• Team Leadership
  • Recruit, develop, and mentor a high performing quality team
• Document Control:
  • Responsible for the management of  document control of the US SOPs and sales & marketing literature
• Training:
  • Manage, update and maintain staff training files, facilitates training of all US staff on Quality System procedures, including document control, non-conformance, CAPA, handling complaints and customer feedback, and SOP training and re-training procedures, and Quality induction for new staff.
  • Ensures new staff adheres to their training schedule and that they provide regular updates for SOP & Training database
• Incoming Quality Checks:
  • Manages and conducts QC of raw materials and testing processes for the laboratory
• Equipment:
  • Ensure that equipment maintenance and servicing is performed according to specifications
  • Ensure that all equipment is validated
• Process Validation:
  • Support validation of laboratory procedures, collect and analyze data, and perform routine document review and special audits
• General QA responsibilities
  • Assist the quality management team with the monitoring of compliance and ensuring the continuing effectivenessof the QMS according to CLIA, CAP, State regulations, ISO 9001, ISO 17025 and the QSR
  • Manages the workload of the Memphis Quality Team.
  • Creates and provides quality metrics to the Quality and Regulatory Manager, Quality teams and other areas as required.
  • Works with UK and US staff to continuously improve the Quality Management System, streamlining documentation and processes where possible with prior communication and assessment of any associated risks.
  • Ensuring a consistent approach across the sites and where needed site relevant processes.
  • Communicates with the UK/US team on issues and activities.
  • Organises team meetings and interdepartmental meetings as required.
  • Project manages quality initiatives as required
• Complaints:
  • Manage the logging and investigation of customer complaints and feedback to the sales team.
  • Completion of complaint metrics to identify trends.
• Audits and Quality Oversight:
  • Manages the internal audit schedule and external quality audits such as CAP and CLIA.
  • Highly visible in the lab organising and conducting regular spot audits.
• Non-conformance and CAPA:
  • Manages the logging, trouble shooting, investigation and progression of issues with non-conforming product, processes or work in a timely manner.
  • Produces regular metrics and identifies and acts on trends.
• Follows all company safety policies & other safety precautions within work area
• Regular attendance and timeliness is essential