Senior Quality Professional

1 week ago

Fermoy, Cork, Ireland beBeeQualityEngineer Full time

About Us

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We are a leading manufacturer of high-quality PCBAs, subassemblies, and complete devices up to and including Class III medical devices.

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Our core specialization is manufacturing automation. We provide services for the entire product lifecycle from New Product Introduction (NPI), prototyping and process validation to complex volume manufacturing & test, shipping and repair.

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We hire people with a range of skills, experience, and backgrounds to fulfill roles in careers such as engineering, quality, and manufacturing.

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Main Objectives:

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  • Ensure customer satisfaction by monitoring, controlling, and improving all related customer processes.">
  • Be the primary customer interface for Quality metrics and improvement initiatives.">
  • Identify, plan, and organize regulatory affairs for ensuring compliance with relevant standards.">
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Responsibilities:

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  • Manage closed-loop customer complaints and improvement processes.">
  • Generate and review Quality Metrics Systems.">
  • Oversee DMR/DHR and Technical Files.">
  • Collect, analyze, and report data.">
  • Analyze Pareto and trends.">
  • Promote Continuous Improvement programs.">
  • NPI Approval including First Article Inspections and Reporting.">
  • CAPA, NCM, and RMA analysis and Improvement.">
  • QSR Validation protocols and reports (IQ, OQ & PQ).">
  • Audit to ensure conformance and effectiveness of the Quality System.">
  • Quality: Ensure ongoing compliance with quality and industry regulatory requirements.">
  • Health & Safety: Ensure compliance with Health & Safety Legislation and Regulations.">
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Performance Indicators:

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  • Yields at Key Process Steps.">
  • Customer Return % and Cost (RMA).">
  • Scrap %.">
  • Outgoing Inspection DPM & Customer Incoming Quality Levels.">
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Requirements:

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  • Minimum NFQ Level 7 Degree/ Diploma in Science or Engineering, or a lesser qualification with sufficient job-related experience.">
  • At least 2-3 years Quality Assurance / Regulatory affairs experience in a similar Quality Engineering role in the electronics manufacturing industry.">
  • Sound understanding and utilization of Problem Solving Techniques.">
  • Proficient in Microsoft Word, PowerPoint, and Excel.">
  • Good Communications and influencing skills.">
  • Ability to respond to common inquiries or complaints from internal customers and regulatory agencies.">
  • Ability to write standard operating procedures, training documents, and regulatory responses.">
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Desirable Qualifications:

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  • Experience in working within a Medical Device Manufacturing Environment or similar.">
  • Six Sigma Green or Black Belt Certified.">
  • Experience in New Product Introduction Processes.">

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