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