Manufacturing Quality Specialist

5 days ago

Athlone, County Westmeath, Ireland beBeeQuality Full time €55,000 - €80,000

Work as a key member of the manufacturing quality team to drive new processes and systems.

Job Description:

  • Lead defined quality activities resulting in improved processes or systems.
  • Develop strategies for sampling methods and implement them effectively.
  • Write up, review, and provide guidance on CAPAs, NC/NCMRs, and SCARs.
  • Perform internal and supplier audits.
  • Support external regulatory body audits.
  • Ensure compliance with all relevant training requirements and adhere to documentation.
  • Follow strict adherence to CGMP requirements.

Required Skills and Qualifications:

  • Degree-level qualification in Quality, Science, or Engineering.
  • Minimum three years' experience working in regulated environments.
  • Medical device change control implementation.
  • Strong computer skills, including MS Excel, PowerPoint, and Word.
  • Familiarity with statistical tools, such as Pareto charts and trend charts.
  • Experience with problem-solving techniques.
  • Effective communication of technical information.

Benefits:

  • Global medical device company.
  • Hybrid working model.
  • Career advancement opportunities.
  • Flexibility to work with different teams within other manufacturing units.

Key Responsibilities:

  • Initiate, review, and approve change controls.
  • Maintain product manufacturing, packaging, and labeling compliance.
  • Develop sampling strategies and implement them.
  • Review CAPAs, NC/NCMRs, and SCARs.
  • Provide guidance to suppliers and engineering.

Requirements:

  • Three years' experience in regulated environments.
  • Medical device change control implementation.
  • Strong computer skills.

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