Senior Quality Specialist

1 day ago

Fermoy, Cork, Ireland beBeeQuality Full time €60,000 - €80,000
Quality Assurance Professional

About this Role:

This Quality Technician role is designed to ensure customer satisfaction by monitoring, controlling and improving all related customer processes. Key aspects include strong interface with customers on quality metrics and improvement initiatives.

Key Responsibilities:

  • Support the development of quality processes including set up, verification and improvements.
  • Perform in-process testing on products.
  • Complete weekly leak and burst testing to verify product sealing as per specification requirements.
  • Verify critical process parameters (CPPs) and line clearance activities.
  • Conduct internal audits to ensure conformance and effectiveness of the quality system.
  • Support audits by demonstrating product testing requirements and best practices.
  • Provide feedback and suggest improvements on customer 'supplier quality issues'.
  • Prepare for and participate in daily engagement process meetings.
  • Identify improvements through quality reviews and meetings on quality, yield, flow, documentation, control etc.
  • Elevate quality issues where necessary and conduct non-conformance investigations when required.
  • Perform weekly environmental monitoring sampling of ISO Class 8 cleanrooms.
  • Prepare and review sterile release packs (Endotoxin & Bioburden test reports).
  • Verify the releasing of sterile products.
  • Support SMT line first-off verifications along with verifying line clearance activities.
  • Review and approve unplanned maintenance activities when required across multiple assembly lines.
  • Determine lot suitability for release by reviewing production logs and final batch records against product specifications, procedures and electronic data systems.
  • Review and approval of Design History Records (DHR) by obtaining and verifying the contents of DHRs against relevant documentation requirements.
  • Interact with manufacturing execution system (MES) and Oracle Agile systems daily to ensure products are assembled as per the required specification.
  • Maintain work space compliance to site requirements, ESD, MSD, Housekeeping (5S), Safety etc.
  • Ensure ongoing compliance with quality and industry regulatory requirements.
  • Comply with Health & Safety Legislation and Regulations.

Requirements:

  • NFQ Level 6 Certificate/Diploma in Science or Engineering or sufficient job-related experience.
  • Sound understanding and application of problem-solving techniques.
  • Proficient in MS Word, Excel and PowerPoint.
  • Good communication and influencing skills.
  • Ability to write standard operating procedures and training documents.

Desirable Qualifications:

  • Experience in a similar quality role in the electronics manufacturing industry.
  • Experience working within a Medical Device Manufacturing Environment.
  • Six sigma Green or Black Belt certified.
  • Experience in New Product Introduction Processes.

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