Senior Product Conformance Specialist

4 days ago

Sligo, Sligo, Ireland beBeeQuality Full time €80,000 - €100,000

Job Summary:

  1. To ensure that products comply with approved specifications and regulatory requirements.
  2. Work as a member of the Quality Team to achieve quality goals and objectives. Ensure all actions comply with current good manufacturing practice.

Key Responsibilities:

  1. Coordinate assigned elements of the Quality System, ensuring full compliance by relevant plant personnel.
  2. Audit the quality system where required.
  3. Assist in investigating customer complaints and coordinating corrective or preventive actions.
  4. Manage day-to-day CAPA requirements by initiating timely and effective investigations and correction actions.
  5. Measure performance of the Quality System and provide metrics for management reviews.
  6. Provide necessary training to plant personnel on quality requirements.
  7. Ensure Management is informed of system failures to facilitate corrective action.
  8. Verify effectiveness of corrective/preventive actions arising from product/process and quality system non-compliance.
  9. Ensure implementation and compliance with regulatory requirements.
  10. Participate in validation activities at the site.
  11. Ensure Quality System documentation is thorough, complete, and compliant.
  12. Review lot records and complete lot release for shipment.
  13. Inspect incoming products and manage supplier relationships.
  14. Participate in continuous improvement programs to improve quality, safety, environmental, and production systems.
  15. Complete product testing per relevant approved specifications and procedures.
  16. Review batch records and complete disposition decisions.

Essential Requirements:

  1. Degree in Engineering, Science, Quality, or other discipline.

Desired Requirements:

  1. Green Belt qualification or demonstrated knowledge of statistics in an industrial environment.

Experience Required:

Technical/Business Knowledge:

  1. 2 years plus experience operating quality systems in regulated combination product/device environments.
  2. Minimum 2 years working knowledge of quality systems regulations (ISO13485/ISO9000; CFR 21 Part 820) or individual elements within the regulations.
  3. Experience in injection moulding or tooling environments is desirable.

Benefits:

This role offers opportunities for professional growth and development.

Why You'll Thrive Here:

Our company values innovation, teamwork, and excellence.

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