Senior QA Engineer

3 days ago

Sligo, Sligo, Ireland beBeeQuality Full time €60,000 - €70,000

Job Title: Quality Assurance Specialist

Job Description

The Quality Assurance Specialist will be responsible for ensuring that products manufactured at the site comply with approved specifications and current good manufacturing practice.

  • Coordinate assigned elements of the Quality System, ensuring full compliance by all relevant plant personnel.
  • Audit the quality system with other personnel as required.
  • Assist in investigating customer complaints and implementing corrective or preventive actions.
  • Manage CAPA requirements, ensuring timely initiation, investigation, correction, and implementation.
  • Measure performance of the Quality System and provide metrics for inclusion in management reviews and reports.
  • Ensure all plant personnel are aware of quality requirements through necessary training.
  • Inform Management of system failures and ensure corrective/preventive action and product containment is taken.
  • Verify effectiveness of corrective/preventive actions arising from product process and quality system non-compliance.
  • Implement and comply with Regulator requirements.
  • Assist in performing validation activities at the site.
  • Evaluate Quality System documentation for thoroughness, completeness, and compliance.
  • Maintain compliance with training requirements.
  • Review lot records to ensure documentation complies with requirements and complete lot release for shipment.
Required Skills and Qualifications
  • Degree in Engineering, Science, Quality, or another discipline.
Benefits
  • Opportunity to work in a highly regulated combination product/device manufacturing environment.
Others
  • Experience in injection moulding or tooling environments.
  • Working knowledge of quality systems regulations (ISO13485/ISO9000; CFR 21 Part 820).
Responsibilities

This role involves responsibility for:

  • Coordinate assigned elements of the Quality System.
  • Audit the quality system with other personnel as required.
  • Assist in investigating customer complaints and implementing corrective or preventive actions.
  • Manage CAPA requirements.
  • Measure performance of the Quality System.
  • Inform Management of system failures.
  • Verify effectiveness of corrective/preventive actions.

Tasks may include:

  • Developing and maintaining quality control procedures.
  • Collaborating with cross-functional teams to identify and address quality issues.
  • Analyzing data to identify trends and areas for improvement.

Key Performance Indicators (KPIs):

  • Quality defect rate reduction.
  • Implementation of corrective actions.
  • Regulatory compliance.

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