Overview

New Product Introduction / Quality Engineer role in a leading medical devices company based in Waterford City. The overall purpose of the New Product Introduction / Quality Engineer is to   

  • Assist in the development and implementation of quality plans, programs and procedures using quality control statistics, lean manufacturing concepts and analyses.  
  • Ensures that performance and product quality conform to established company, customer and regulatory requirements, supports New Product Introduction activities relating to Quality for products, processes or technologies, and for the enhancement or extension of existing product lines.

ESSENTIAL DUTIES AND RESPONSIBILITIES (include the following; other duties may be assigned):

  • Develop and maintain QA plans and process routings, which reflect intended/actual activities.
  • Provide support for all quoting activities by participation in initial process design, development, and implementation phases.
  • Evaluate and support inspection processes via inspection aids and instruction guidelines.
  • Support all training programs by development and implementation of specialized training sessions for all applicable functions.
  • 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.
  • Provide trend analysis of defects occurring at the customer, supplier and internally.
  • 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 with special regard to ISO, EN4600 and GMP documentation.
  • Monitor departmental activities and provide technical and logistical guidance/support for the quality engineering staff as applicable.
  • Interface and provide technical support on quality issues with the customer as needed.
  • Support and focus corrective action efforts and utilizing the SPC data and corrective action tracking package and create and implement any meetings, procedures, or team-building concepts as necessary as part of the corrective/preventative effort.
  • Serve as liaison between the company and suppliers or customers on quality related issues.
  • Improve technical support for the quality organization.
  • 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
  • 2 years related experience; or equivalent combination of education and experience in Medical Device and/or Pharma Industry.
  • Preferably with Knowledge/experience of manufacturing engineering, exposure to high volume medical device or pharma automated assembly lines.
  • Excellent organization, communication, computer & presentation skills.
  • Excellent initiative, decision making and be able to work in a core team environment.
  • Excellent time management skills.
  • Solution driven with emphasis on performance and results.

 

 

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