Quality Engineer

 

Description:

The Role Involves
 

  • Utilizing Quality Engineering tools and practices for the effective and efficient development and/or transfer of products/processes into commercial operations
  • Utilizing Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision
  • Utilizing appropriate risk management to prevent unanticipated failure modes and improve the capability of processes
     

Responsibilities
 

  • Team member representing the Quality function supporting projects in with a focus on metals forming processes
  • Support Quality and Validation activities for product transfers and new product introductions
  • Responsible for ensuring conformance with current equipment, process, and systems validation regulations
  • Determine the implications of validations upon, Product Quality, Patient Safety, and Data Integrity
  • Assess effectiveness of measurement tools, destructive test, non-destructive tests (measurement system analysis)
  • Determine process inputs and factors for variation where process capability is required
  • Responsible for reviewing Installation, Operating and Performance Qualification (IQ, OQ, PQ) s
  • Responsible for conducting Test Method Validations as required
  • Develop/Review PFMEA documentation to support processes as part of Validation process
  • Partner with other cross functional partners to ensure the correct application of design controls, risk management and the investigation/correction of design failures/challenges
  • Conduct investigation, bounding, documentation, review, and approval of non-conformances and CAPAs related to Materials projects. Escalation of quality issues as appropriate
  • Support root cause analysis activities related to material processes
  • Communicate effectively with internal team on actions and deliverables
  • Provide timely and accurate reporting and management of escalations as appropriate on project activities
  • Ensure all activities comply with GMP, ISO and quality system requirements
  • Ensure that all health, safety, and environmental requirements are fulfilled
     

Minimum Qualifications and Experience
 

  • BSc in Engineering or Science with 2 years' experience in a medium to high volume manufacturing environment
  • 1 year in a similar capacity in a regulated industry (i.e., FDA/ISO)

Organization Kvalito Consulting Group
Industry Engineering
Occupational Category Quality Engineer
Job Location Cork,Ireland
Shift Type Morning
Job Type Full Time
Gender No Preference
Career Level Intermediate
Experience 1 Year
Posted at 2024-04-13 10:06 am
Expires on 2024-12-05