Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • Luimneach

Description

Company Introduction
Vision Care Ireland is located in Limerick and produces the Acuvue range of contact lenses: the world’s leading contact lens product.  Our Limerick site uses the industry’s most advanced technology and directly employs over 1000 people. We produce a diverse array of contact lenses using our highly automated production process.  Key to our success has been the combination of state-of-the-art material science with technologies such as precision injection moulding, robotics, vision systems and data analytics.
 
Vision Care Ireland was established in 1995 in the National Technology Park, close to the University of Limerick.  The facility opened with six production lines that manufactured one day disposable contact lens for the European and Japanese markets.  Since then we have been on a continuous expansion and improvement path and now have over 37 advanced production lines, manufacturing over 8 million contact lenses a day, which are shipped to customers worldwide.
 
Role Summary:
Provides overall quality assurance leadership in the management and qualification of suppliers and/or external manufacturers (EMs).  Establishes and maintains quality assurance programs, procedures and controls, ensuring that performance metrics of both the supplier quality systems and suppliers are continually measured to drive improvement initiatives.  This position aids in the identification and eliminate supply chain risks via internal and supplier partnerships.  Leads/participates in supplier/EM engagements to assess technical competency and general compliance to requirements, i.e., material specifications, CTQ’s, process control plans, quality agreements, etc.  Key areas of focus within supplier management are performance monitoring/reporting, compliance to J&J standards and stream line processes.  Key areas of support provided to team members include; risk management/communication, defect resolution, process capability/process improvement, and quality assurance general support. 
 
Responsibilities:
Performs quality processes including; change control, supplier non-conformance, quality agreements.  Participate in local site supplier/EM quality meetings to ensure communication and alignment of quality initiatives.  Lead supplier/EM quality evaluations.  Provide third party inspection support.  
·         Lead defect resolution, root cause investigation, and continuous improvement activities.  Collaborate across functions to confirm if non-conformances are supplier/EM related as applicable.
·         Support internal and/or external cross-functional and cross sector project teams driving supplier/EM improvement and general initiatives through reducing variations in supply chain, institute control plans, and improving process capability.  Provide Quality Engineering support to suppliers/EMs including verification/validation activities.  Apply Quality Engineering tools such as Failure Mode & Effects Analysis (FMEA), Fault Three Analysis (FTA), Root Cause Analysis, Design of Experiment (DOE) etc., to the development of new products or processes related to raw materials, services, and finished products.
·         Accountable, as applicable   for compliance in accordance with regulations such as and from, but not limited to, FDA Quality System Regulation, ISO 13485, EU MD Directive/Regulations,   FDA, 21 CFR 820; FDA Combo Product Regulation 21 CFR Parts 4 with 21 CFR 210/211, Japanese MHLW, Health Canada, Brazilian ANVISA,   Australian TGA for the company's products including medical devices and combination products.
Maintain, support compliance of, and improve supplier/EM quality processes, including procedural and electronic systems. Support alignment with enterprise standards and executing gap assessments.  Provide regulatory guidance and interpretation to internal and external partners with regards to the following areas:  EM and Supplier Quality procedures, medical devices, and combination products.
Deliver:
Evaluate processes to determine if refinements would enhance speed of results and productivity.
Share ideas on how results can be achieved more quickly.
Examine the quality of products and customer service. Identify steps to improve in these areas.
Build & reinforce a sense of urgency on key projects; help others understand the criticality of these efforts.
Listens and responds effectively, seeks clear requirements, and follows up in a timely

About the company

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