Job Title
Role Overview: The Quality Assurance Manager will play a crucial role in ensuring customer satisfaction by monitoring, controlling, and improving all related processes.
Key Responsibilities:
* Management of closed loop customer complaints and improvement processes
* Generation and review of Quality Metrics System
* Overall responsibility for DMR/DHR and Technical Files
* Data collection, analyzing, 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 report (IQ, OQ & PQ)
* Conducting Audits to ensure conformance and effectiveness of the Quality System
Requirements
Essential Skills:
* 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 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
Desirable Qualifications: Experience in working within a Medical Device Manufacturing Environment or similar, Six Sigma Green or Black Belt Certified, and experience in New Product Introduction Processes.