Sr. Quality Engineer

Sr. Quality Engineer – Santa Clara, CA (Onsite) 🚨
We are currently looking for a Senior Quality Engineer to join a leading organization in a highly regulated industry (Medical Device preferred).
📍 Location: Santa Clara, CA (Onsite)
💼 Role: Sr. Quality Engineer
📅 Experience: 5–8+ years
🔧 Key Responsibilities:
Lead supplier qualification, onboarding, and audits
Drive APQP, PPAP deliverables and supplier readiness
Manage NC / CAPA / SCAR and ensure effectiveness verification
Support IQ/OQ/PQ validation and SPC implementation
Monitor supplier KPIs and drive continuous improvement
Support design transfer, risk management, and verification activities
Review DHF/DMR quality deliverables for compliance
Develop inspection plans based on CTQs
🛠 Must-Have Skills:
Windchill (PLM)
ETQ (eQMS)
SAP (BtB processes, QN, inspection lots, material master)
Strong experience in APQP, PPAP, PFMEA/DFMEA, MSA, SPC
RCA methodologies (8D, DMAIC)
⭐ Nice to Have:
Experience in packaging (Case & Tray) or sterile barrier systems
Six Sigma / ASQ certification
🎯 Requirements:
Bachelor’s degree in Mechanical / Biomedical / Industrial Engineering or related
5–8+ years of Supplier Quality Engineering experience