製品品質エンジニア(Sr Product Quality Engineer)/ 相模原事業所 FSDフィルター製品事業部
Core
Ensures product quality and reliability across the lifecycle from new product development to manufacturing, change management, and customer use for filtration and separation products serving pharmaceutical, food, beverage, electronics, and industrial markets.
Role type
Senior Product Quality Engineer (Filtration & Separation)
Builds
Filtration and separation solutions for global markets
Domain
Industrial filtration, pharmaceutical manufacturing, food & beverage, electronics
Required skills
Quality assurance in industrial sectors, cGMP/ISO 13485/9001/FDA/EMA regulations, CAPA and deviation management, Change Control, Risk Management and FMEA, Internal and external auditing, Root Cause Analysis, Cross-functional collaboration, Supplier communication, Meeting facilitation
Preferred skills
Engineering/Life Sciences/Chemistry background, Quality management software, Validation and qualification protocols, Statistical analysis, Project management, Troubleshooting, Written and verbal communication, Multitasking
Technologies
Quality management software, Microsoft Office
Responsibilities
Support product quality and reliability from development through manufacturing and customer use; Prevent quality issues and investigate incidents; Create and maintain documentation per new product development and change management systems; Troubleshoot product defects; Collaborate cross-functionally to resolve quality issues; Communicate with external suppliers regarding raw and intermediate materials; Facilitate related meetings globally
Seniority
Senior, hands-on IC