Our Global Medical Device clients are currently recruiting for a Quality Manager on a permanent basis in Essex.
Participate in the design and manufacturing process to ensure products meet SQCD requirements. Deputise for the Quality Management Systems Representative. Provides strategic direction to all quality assurance activities in support of the company’s objectives. Assures that quality assurance procedures, processes, practices and controls are properly developed, implemented and maintained. Assures that all products represent the maximum quality and reliability attainable. Routinely provides guidance and leadership to engineers, inspectors and/or technicians for the duration of a project assignment. Key role in ensuring product issues are promptly investigated and adequate corrective/preventive action implemented e.g. customer complaints, out of specification components, etc. Ensures the CAPA systems are operating effectively and close out of corrective actions meets expected deadlines.
This position is nominated as Deputy Person Responsible for Regulatory Compliance (PRRC) under EU MDR 2017/745 article 15(3) for the areas described in Art 15(3)(a).
* Supervision and management of Team of Quality Engineers, Technicians and Quality Controllers
* Resource planning
* Generate control plans
* Review and approval of technical documents
* Problem solving
* Supply chain development
* Project management
* Drive regulatory compliance strategies
* Develop and ensure quality, regulatory and management reports are accurate and delivered within agreed timelines.
* This position is nominated as Deputy Person Responsible for Regulatory Compliance (PRRC) under EU MDR 2017/745 article 15(3) for the areas below:
* Art 15(3)(a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released.
* Product compliance testing & reporting
* Participate in Continuous Improvement activities
Will undertake any assignment or duty as required by business needs and assigned by line management.
Qualifications & Experience:
* Degree, or equivalent, in an Engineering or Life-Sciences Discipline.
* Five years’ experience in a Quality Systems and/or Engineering role within an Electro-Mechanical or Electronics or Sterile Medical Devices Manufacturing environment.
* Experience in a Medical Device facility.
* Good understanding of EU MDD/MDR, ISO 13485 requirements, FDA QSR and JPAL requirements and other key international regulations covering medical and industrial devices.
Proven track record in a supervisory role
Quality Management Systems
Medical Device Directive
Corrective And Preventive Action (Capa)