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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:
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- 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
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Accountable for creating and maintaining internal audit schedules and records including tracking CAPA and Non-Conformance activities
- Medical device supplier management
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Managing the execution of Notified Body audits and track progress of responses
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Quality Management System training throughout the business
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Review risk throughtout the QMS and business
- People management
