Manufacturing Process Specialist

2 weeks ago

Galway, Galway, Ireland beBeeManufacturing Full time €60,000 - €80,000
Job Overview

As a seasoned manufacturing professional, you will play a pivotal role in spearheading the optimization of our production processes for neuro medical devices. Your expertise will be instrumental in collaborating closely with cross-functional team members to ensure seamless and efficient production workflows.

  • Lead the design, implementation, and continuous improvement of manufacturing processes for our flagship device, encompassing product assembly, testing, and packaging.
  • Provide hands-on technical support to the manufacturing line, ensuring smooth day-to-day operations and swift resolution of issues.
  • Proactively monitor line performance, efficiency, and output, utilizing data-driven insights to drive improvements.
  • Ensure all manufacturing activities are conducted in compliance with our Quality Management System (QMS) and applicable policies, including accurate documentation and comprehensive reporting.
  • Identify and implement efficiency enhancements to streamline manufacturing workflows and reduce waste.
  • Support the introduction of new product lines by establishing robust manufacturing processes, tooling, and fixtures.
  • Plan, execute, and document process validation activities in alignment with regulatory and quality system requirements.
  • Participate in process risk assessments and contribute to mitigation strategies to ensure robust manufacturing operations.
  • Lead and support continuous improvement initiatives focused on optimizing product yield, reducing cycle time, and maximizing resource utilization.
  • Collaborate cross-functionally with R&D, Quality Assurance, and Regulatory Affairs to ensure compliance with industry regulations and internal standards.
  • Develop, review, and maintain detailed process documentation including work instructions, inspection procedures, and batch records to ensure clarity, traceability, and compliance.
  • Maintain full traceability of finished goods in accordance with regulatory and internal requirements.
  • Manage equipment lifecycle activities, including specification, procurement, installation calibration, and preventive maintenance.
  • Represent the company during external engagements such as physician line tours, showcasing manufacturing capabilities and quality practices.
  • Coordinate with suppliers regarding delivery schedules, quality concerns, and continuous improvement opportunities.

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