As a Quality Manager, you will be an integral part of the Europlaz operation, you will work closely with both the senior management and technical teams to ensure the QMS is maintained in line with ISO13485 requirements, other applicable regulatory requirements, and our customer’s expectations.
The Quality Manager reports to the Head of Quality and Regulatory Affairs.
As a Quality Manager you will be responsible for planning, organising, leading and controlling Quality Management activities. You must also ensure that systems and controls are in place to maintain the safety of the medical devices we manufacture and compliance to all Quality System requirements.
Understand needs of the QMS and maintain effective, quality-assured processes
Understand customer needs to maintain effective quality assured processes
Manage updates and ongoing improvements of the QMS to existing and new standards, regulatory and customer requirements
Manage all customer feedback including complaints and ensure these are dealt with in a timely and compliant manner and are properly communicated throughout the business
Be on the lookout for opportunities for continual improvement and develop new efficient & effective procedures
Provide guidance and feedback for Supervisors, Quality Inspectors, and other staff
Drive change and improvement in performance and quality
Deputise for Head of Quality Assurance & Regulatory Affairs
Manage the batch release and labelling approval process
Manage cleanroom compliance
Perform internal and external audits as per plant auditing schedule
Ensure that new regulations are communicated and effectively implemented
Be responsible for the management of the plant CAPA system
Be responsible for the management of the plant NCR system
Provide data and information for management review and KPI’s
Person Specification Requirements
Proven experience as a Quality Manager (QMS or Assurance) preferably in medical devices.
An excellent working knowledge of ISO13485:2016
ISO13485 auditing qualified
Lead auditor qualification for ISO13485:2016 or experience of auditing to a similar standard i.e. ISO13485, ISO9001 would be advantageous.
In depth understanding of quality procedures and regulatory standards
Experience in problem solving techniques
Experience and capability in root cause analysis, leading issue investigation and resolution, documentation and testing
Excellent organisational and time management skills
Strong attention to detail
Ability to prioritise effectively to firm deadlines
People management is an advantage
Proactive with track record of delivering against objectives
Ability to communicate with all levels within the business
Full-time, permanent. The role is 40 hours per week with 30 minutes for lunch. Hours of work are 8.30 a.m to 5.00 p.m and an early finish on a Friday. There is flexibility on the start time. Very competitive salary for the right candidate.
How to apply
To apply please complete the form below and upload your CV and Covering Letter.