Job Description
NPI/Quality Engineer for County Waterford
CORE DUTIES AND RESPONSIBILITIES:
* Develop and maintain QA plans and process routings, reflecting intended/actual activities.
* Support quoting activities by participating in initial process design, development, and implementation phases.
* Evaluate and support inspection processes via inspection aids and instruction guidelines.
* Support all training programs by developing and implementing specialised training sessions for applicable functions.
* Conduct periodic review and maintenance of documentation files; develop systems for document storage and access.
* Review supplier or customer discrepancies, coordinate and track corrective/preventative action efforts.
* Provide trend analysis of defects occurring at the customer, supplier, and internally.
* Participate in vendor survey activities as applicable.
* Drive proactive participation with suppliers and aid in their process improvement efforts.
* Interface with departments regarding ISO, EN4600, and GMP documentation.
* Monitor departmental activities and provide technical guidance/support for quality engineering staff.
* Interface with customers on quality issues and provide technical support.
* Focus corrective action efforts using SPC data and tracking packages, and create meetings, procedures, or team-building concepts as necessary.
* Serve as liaison with suppliers or customers on quality-related issues.
Required Qualifications:
* Bachelor's degree.
* At least 2 years' relevant experience in Medical Device and/or Pharma industry, or equivalent combination of education and experience.
* Prior knowledge/experience of manufacturing engineering, high-volume medical device or pharma automated assembly lines is preferred.
* Excellent organisation, communication, computer, and presentation skills.
* Initiative, decision-making, and ability to work in a core team environment are essential.
* Effective time management and solution-driven approach with emphasis on performance and results.