Quality Assurance Manager - Pillans Group Ltd : Job Details

An exciting opportunity has arisen within Pillans Group Ltd for a full-time Quality Assurance Manager working at our Head office in Kendal. Our Quality & Regulatory Division is responsible for medical regulatory compliance for several companies including Q Medical Technologies Ltd and provides other services including UK RP and UK Importer.

This is a great opportunity to join a fast growing team, reporting directly to the Managing Director and working closely with various functions including Operations & Sales, whilst providing business support and guidance in line with Compliance company strategies.

Key Responsibilities

• Involved in the and maintenance of regulatory compliant Quality Management System (QMS) documentation that will include, but not be limited to:
• • QMS reports & analysis
  • Quality reports for review at Management Review meetings
  • Reviewing and actioning feedback from customers
  • Support creation, revision and maintenance of Operating Procedures, Quality Forms and Work Instructions
  • Identification, investigation and documentation of product and process non-conformances document root cause and corrective actions, liaising with relevant departmental representatives to ensure sustained ongoing adherence to quality system requirements.
  • Manage quality requirements & processes for the business

• Accountable for creating and maintaining internal audit schedules and records including tracking CAPA and Non-Conformance activities

• Medical device supplier management

• Managing the execution of Notified Body audits and track progress of responses

• Quality Management System training throughout the business

• Review risk throughtout the QMS and business

• People management