Product Quality Assurance Specialist

1 day ago

Loch Garman, Loch Garman, Ireland beBeeRiskAssessor Full time €90,000 - €125,000

Key aspects of this role involve ensuring quality and risk management throughout the lifecycle of new product development (NPD) projects.

Quality Objectives

The primary focus is to guarantee that all processes are correct, effective, and efficient, resulting in the highest-quality products and services for customers and their patients.

This position requires collaboration with cross-functional teams to ensure compliance with design control requirements for NPD projects and all design elements. Key responsibilities include:

  • Reviewing design control compliance requirements
  • Developing UFMEA & DFMEA, coordinating guidance from other design sub-team members and supporting PFMEA development
  • Performing DOE's and statistical analysis to support product and process optimization or resolve causes of process variation
  • Initiating corrective actions as required
  • Supporting assessment of biocompatibility testing per ISO10993 and company procedures
  • Participating in internal audit and supplier audit programs

Additional details about this role will be discussed during an interview. Candidates must possess a strong understanding of quality engineering principles and practices.

Requirements

To excel in this position, candidates should have:

  • A bachelor's degree in a relevant field such as engineering or a related discipline
  • Proven experience in quality engineering, including UFMEA, DFMEA, and PFMEA development
  • Strong analytical and problem-solving skills
  • Excellent communication and collaboration skills
  • Ability to work effectively in a team environment

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