Product Quality Assurance Specialist

2 days ago

Ballina, Mayo County, Ireland beBeeQuality Full time €81,648 - €105,696
Product Quality Assurance Specialist

We are seeking a detail-oriented Product Quality Assurance Specialist to join our team. This role is essential in ensuring compliance with regulatory standards and product quality through the investigation of customer complaints, implementation of corrective and preventive actions (CAPAs), and cross-functional collaboration.

Main Responsibilities
  • Investigate Customer Complaints thoroughly, identifying root causes and ensuring timely resolution in compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable regulations.
  • Develop, implement, and monitor Corrective and Preventive Actions (CAPAs) to mitigate identified risks and prevent recurrence of quality issues.
  • Analyze data related to product performance, complaints, non-conformances, and process deviations; present findings in a clear and actionable manner.
  • Maintain high-quality technical documentation, including investigation reports, CAPA records, risk assessments, and trend analyses.
  • Collaborate closely with cross-functional teams (R&D, Manufacturing, Regulatory Affairs, and Customer Service) to drive resolution of quality issues and ensure compliance with internal and external standards.
  • Support internal and external audits by preparing documentation, participating in audit activities, and following up on audit findings.
Required Skills
  • Bachelor's degree in Engineering or Life Sciences.
    • Minimum 5 years quality assurance experience in a regulated industry.
  • Strong understanding of FDA QSR, ISO 13485, and relevant international regulations.

This role plays a key part in maintaining product integrity, analyzing data trends, and supporting regulatory submissions through technical documentation. The successful candidate will work effectively across departments, managing multiple tasks and projects in a fast-paced environment.

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