Supplier Quality Engineer - Regulated Medical Devices

Bio-Techne; San Jose (CA); On-site; USD 80,000 - 131,000; Full time

Benefits offered by this job

Medical insurance

401k & ESPP

Tuition reimbursement

Paid time off

Job summary

Bio-Techne is hiring a Supplier Quality Engineer in San Jose to oversee supplier qualification, audits, and quality systems across manufacturing and supply chains.

The role partners with Quality, Purchasing, Manufacturing, Engineering, and Supply Chain to drive improvements, manage CAPAs, and support new product introductions. Onsite work is required with travel up to 25% domestically.

Qualifications

• Bachelor’s degree in engineering or related field.
• 2–5 years in supplier quality or process engineering.
• Experience in a regulated manufacturing environment.

Responsibilities

• Qualify, onboard, and evaluate new suppliers via audits and quality reviews.
• Lead SCARs, root cause analysis, corrective actions and verification.
• Perform supplier/audit activities to ensure ISO 13485, ISO 9001, MDSAP compliance.
• Support PPAP, new product introductions, and manufacturing transfers.

Skills

Analytical skills

Problem solving

Communication

Cross-functional collaboration

Supplier quality systems

Root cause analysis

Project management

Auditor experience

PPAP

FMEA

SPC

ISO 13485

Education

Bachelor's degree in engineering or related field

Job description

Bio-Techne is hiring a Supplier Quality Engineer in San Jose to oversee supplier qualification, audits, and quality systems across manufacturing and supply chains.

The role partners with Quality, Purchasing, Manufacturing, Engineering, and Supply Chain to drive improvements, manage CAPAs, and support new product introductions. Onsite work is required with travel up to 25% domestically.