Experienced Quality Control Professional Wanted

6 days ago

Waterford, Waterford, Ireland beBeeLeadership Full time €60,000 - €80,000
Quality Assurance Specialist

The purpose of this role is to assist in the development and implementation of quality plans, programs, and procedures using quality control statistics, lean manufacturing concepts, and analyses.

This specialist ensures that performance and product quality conform to established company, customer, and regulatory requirements.

Key Responsibilities:

  1. Provide technical support during the NPI process to ensure compliance with FDA, QSR, MDR & EU GMP standards/guidelines for device classifications.
  2. Apply quality engineering tools and techniques with emphasis on validation protocols (DQ, IQ, OQ, & PQ), cGMP, FMEAs & generate regulatory documents as required.
  3. Support the development of a compliant manufacturing process aligned to customer expectations, ensuring operational readiness post validation.

The successful candidate will have experience in sterilization, automation, equipment/software validation, manufacturing within controlled environments.

Responsibilities include supporting external & internal Quality Management System auditing functions, CAPA systems, and implementing policies and GMP.

Requirements:

  • Bachelor's Degree in a life science discipline.
  • 2-4 years of experience in manufacturing (preferably Medical Device/Pharmaceuticals).
  • Strong organizational skills are required to plan, execute, and track quality commitments.
  • Working knowledge of ISO 13485 &/or Pharmaceutical EU GMP (Eudralex Volume 4).
  • Experience in performing audits of quality systems to ISO/GMP standards.
  • Excellent leadership skills, ability to motivate team members.
  • Excellent communication, computer, and presentation skills.
  • Ability to work effectively in a team environment.

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