Overview

NPI/Validation Engineer

NPI/Validation Engineer required by leading medical devices company based in Waterford City. The overall purpose of this role is

  • to represent the quality function in technical support, in conjunction with other internal support groups, regarding issues affecting manufacturing on global customer accounts.
  • Serve as liaison between the company and suppliers or customers on global quality related issues.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

  • Develop and maintain QA plans and timeliness of global new product introductions utilising Advanced Product Quality Planning and Process Optimization specific to the customer.
  • Provide support for all quoting activities by participation in initial process design, development, and implementation phases.
  • Evaluate and provide input to inspection processes via inspection aids and instruction guidelines.
  • Support all global training programs specific to their customer by development and implementation of specialized training sessions for all applicable functions.
  • Develop appropriate systems for document storage, access and review pertaining to global customer accounts.
  • Review all supplies, internal, and customer discrepancies, coordinate and track the effectiveness of corrective/proactive action efforts.
  • Conduct periodic review and maintenance of all documentation files; develop appropriate systems for document storage and access.
  • Review all supplier or customer discrepancies. Coordinate and track the corrective/preventative action effort.
  • Participate in the vendor survey activities as applicable. Drive proactive participation with suppliers and (when possible) aid in their process improvement efforts.
  • Interface with all departments as applied to the Policies and Procedures.
  • Provide insight and assistance of implementing and maintaining Process Improvement and Optimisation concentrating on proactive methodologies.
  • Assist in driving the standardization of manufacturing processes of global customer accounts.
  • Interface and provide technical support on quality issues with the customer as needed.
  • Adhere to all safety and health rules and regulations associated with this position and as directed by supervisor.
  • Comply and follow all procedures within the company security policy.

MINIMUM REQUIREMENTS

  • Bachelor's degree required and five years related experience; or equivalent combination of education and experience.

 

 

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