Europlaz Technologies is a leading contract medical device manufacturer

Europlaz Technologies leading contract medical device manufacturer

Quality Manager

Europlaz is a contract medical device manufacturer certified to ISO 134185:2016. We are seeking a highly motivated and well-organised Quality Manager to continue the maintenance of our ISO accreditation and help further develop and improve processes in line with the business needs. 

As an integral part of Europlaz’s operations, you will work closely with both the senior management and the technical teams to ensure the QMS is maintained in line with ISO13485 requirements, other applicable regulatory requirements, and our customer’s expectations. 

The ideal candidate should have a significant experience in a quality management role preferably in the medical device field. They should have an excellent working knowledge of ISO13485:2016. Lead auditor qualification for ISO13485:2016 or experience of auditing to a similar standard i.e. ISO13485:2003, ISO9001 would be advantageous.

Reporting to the Head of Quality and Regulatory Affairs

Job Description

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 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 process
  • 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

Requirements

  • Proven experience as Quality Manager (QMS or Assurance)
  • ISO13485 auditing qualified
  • 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 organizational and leadership skills
  • People management is an advantage
  • Proactive with track record of delivering against objectives
  • Ability to communicate with all levels within the business