Posted: 14 March
Offer description
Job Description
We are a medical device company that makes a tangible difference in people's lives. We're a modern electronics factory, offering the opportunity to develop and build a career with the latest technologies.
Our Fermoy, Ireland, facility is FDA registered and certified for the manufacture of high-quality PCBAs, subassemblies, and complete devices up to Class III medical devices.
We specialize in manufacturing automation, providing services throughout the product lifecycle from New Product Introduction (NPI), prototyping, and process validation to complex volume manufacturing & test, shipping, and repair.
Quality Engineer
* Ensure customer satisfaction by monitoring, controlling, and improving all related customer processes.
* Principal customer interface for Quality metrics and improvement initiatives, identifying, planning, and organizing regulatory affairs for ensuring compliance with international standards.
Responsibilities:
* Manage closed-loop customer complaints and improvement processes.
* Generate and review Quality Metrics Systems.
* Oversee DMR/DHR and Technical Files.
* Data collection, analysis, and reporting.
* Pareto and trend analysis.
* Initiate and drive 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).
* Audits to ensure conformance and effectiveness of the Quality System.
Measurements:
* Yields at Key Process Steps.
* Customer Satisfaction Index (CCN, CSO, etc).
* Customer Return % and Cost (RMA).
* Scrap %.
* Outgoing Inspection DPM & Customer Incoming Quality Levels.
Personnel Specifications
Essential:
* 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.
Desirable:
* Experience in working within a Class 3 Medical Device Manufacturing Environment.
* Six Sigma Green or Black Belt Certified.
* Experience in New Product Introduction Processes.
