Process Quality Expert

3 days ago

Waterford, Waterford, Ireland beBeeQuality Full time €50,000 - €70,000
Job Title: Process Quality Expert

The primary role of a Process Quality Expert is to formulate and execute quality plans, programs, and procedures that foster excellence in performance and product quality, adhering strictly to established company, customer, and regulatory standards.

Key Responsibilities:
  • NPI Support: Provide technical assistance during the NPI process to ensure compliance with FDA, QSR, MDR & EU GMP guidelines for device classifications.
  • Validation Protocols: Utilize quality engineering tools and techniques, including validation protocols (DQ, IQ, OQ, & PQ), cGMP, FMEAs, and DMFs to develop compliant manufacturing processes aligned to customer expectations.
  • Continuous Improvement: Implement continuous improvement methodologies and process capability analysis to provide robust defect-free processes.
  • Transfer of Ownership: Facilitate the transfer of ownership from NPI to Production phase, collaborating with Programmes group and operational workcell.

Requirements:

  • Bachelor's Degree in a life science discipline.
  • 2-4 years experience in manufacturing (preferably Medical Device/Pharmaceuticals).
  • Working knowledge of ISO 13485 &/or Pharmaceutical EU GMP (Eudralex Volume 4).

Skillset Includes: Quality Engineering, Validation, CAPA, and GMP.

Responsibilities: In this challenging position, you will be responsible for ensuring the development and implementation of quality plans, programs, and procedures that promote excellence in performance and product quality, adhering strictly to established company, customer, and regulatory standards.

Benefits: As a Process Quality Expert, you will have opportunities for professional growth, collaboration with cross-functional teams, and participation in continuous improvement initiatives.

Opportunities: This role provides a unique chance to make a significant impact on the organization's quality culture and contribute to the success of our business.

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