Job Title: Quality Assurance Specialist
Job Description:
Our team seeks a Quality Assurance Specialist to ensure customer satisfaction by monitoring, controlling, and improving all related customer processes. This role serves as the principal customer interface for quality metrics and improvement initiatives.
Responsibilities:
• Management of closed-loop customer complaints and improvement processes
• Generation and review of quality metrics systems
• Overall responsibility for DMR/DHR and technical files
• Data collection, analysis, and reporting
• Pareto and trend analysis
• Initiation and driving of continuous improvement programs
• NPI approval, including first article inspections and reporting
• CAPA, NCM, and RMA analysis and improvement
• QSR validation protocols and reporting (IQ, OQ & PQ)
• Conducting audits 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 and safety legislation and regulations
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 the use of Microsoft Word, PowerPoint, and Excel
• Good communication 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
Desirable:
• Experience working within a medical device manufacturing environment or similar
• Six Sigma Green or Black Belt certified
• Experience in new product introduction processes