MAIN PURPOSE OF JOB AND OBJECTIVES
Ensure stable, effective, capable and well-documented manufacturing processes
Continual improvement of product quality, sustained reductions in product cost
Quick and effective responses to market requirements, and compliance with all applicable regulatory laws and requirements
Maintain awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectives
KEY DUTIES
Continually review all manufacturing processes to document, measure, refine and improve process capability and improve process effectiveness
Identify and deliver continuous improvement programs to deliver cost savings in line with overall manufacturing objectives
Liaise with all relevant departments on the transfer of new products into manufacturing and ensure that all the appropriate specifications and packaging materials are available
Thorough knowledge of FMEA and DOE processes
Develop, initiate, and manage implementation of ECOs to address product quality, cost, and design issues
Ensure that appropriate manufacturing test and validation is performed on materials and processes employed in the manufacture of products; ensure appropriate testing is performed to confirm the “fit and function” of products
Generate drawings when required and review/approve artwork to ensure correct implementation
Ensure root cause investigations are carried out in response to reported product defects
Analyse and approve corrective actions proposed to address quality issues Monitor field response to confirm the effectiveness of implemented corrective actions
Identify cost savings opportunities in materials and processes; plan and perform testing to validate changes that capitalize on these opportunities; document and release changes
Assess opportunities for transfer of product manufacture from inter-company and to Contract Manufacturers Facilitate the transfer of manufacturing process knowledge and technology to allow production relocation
Participate in QS audits manufacturing; ensure appropriate action is taken in response to audit findings
Support QS group in development of a Quality System structure in line with revised ISO 13485; ensure manufacturing compliance to applicable regulatory laws and requirements
Support the provisions of quality data/reports/charts for the manufacturing group
Generate Quality input for Supplier performance management process
Generate relevant required documentation in support of regulatory updates and filings
Supervise assigned engineers within the Manufacturing engineering team, to ensure individual allocated tasks are met within agreed timescales, allocating tasks to team members as appropriate
Perform any other duties/tasks/projects as require by management
Assume other responsibilities from time-to-time in order to support plant’s strategic plan and personal career plans
QUALIFICATIONS & EXPERIENCE
Degree qualified to a minimum of Batchelor degree
Black Belt Six Sigma is desirable but a Green Belt Six Sigma would be satisfactory
Solid manufacturing engineering experience is essential
Possess supervisory experience and strong interpersonal, planning and organisational skills
Experience of Lean manufacturing principles, ie SMED, VM, 5S etc would be advantageous
Strong computer skills and industry knowledge
Strong project management experience