Principal Supplier Quality Engineer

BioTalent; Fremont (CA); On-site; USD 140,000 - 180,000; Full time

Benefits offered by this job

Full medical, dental, and vision; KPI‑

stock options

Job summary

BioTalent in Fremont, CA is seeking a Principal Supplier Quality Engineer to build and own the supplier quality program for a growing medical device company. This is a brand-new role with end-to-end responsibility for supplier qualification, audits, monitoring, and performance management.

Onsite 3 days per week with up to 50% travel to the South Bay, you will lead supplier qualification of contract manufacturers, oversee audits, drive SCAR resolution, and partner with Engineering, Operations,

Qualifications

• 8-10+ years in Quality Assurance / Supplier Quality in medical devices.
• FDA 21 CFR Part 820/QMSR knowledge.
• ISO 13485 knowledge.
• Experience qualifying, auditing, and managing suppliers (SCAR).
• Medical robotics/orthopedic implants or electromechanical devices preferred.
• Experience building a supplier quality program from scratch a big plus.
• ASQ CQE, CSQP, CQA, or ISO 13485 Lead Auditor certification preferred.
• Travel up to 50% to South Bay suppliers.

Responsibilities

• Design and lead a complete Supplier Quality Management Program.
• Lead qualification and oversight of contract manufacturers and suppliers.
• Plan, conduct, and report supplier audits and assessments.
• Own SCAR initiation to verification of effectiveness.
• Investigate supplier quality issues and drive root cause analysis and corrective actions.
• Build and maintain supplier scorecards and risk profiles.
• Partner with Engineering, Operations, Manufacturing, Supply Chain, and Regulatory Affairs.
• Support FDA inspections and external audits.
• Apply risk-based decision-making per ISO 14971.

Skills

Quality Assurance

Supplier Quality

Auditing

Root Cause Analysis

Education

ASQ CQE

CSQP

CQA

ISO 13485 Lead Auditor

Job description

Fremont, CA (Onsite 3x/week with up to 50% travel to South Bay)

We're looking for a Principal Supplier Quality Engineer to build our supplier quality management program from the ground up. This is a brand-new role — you'll be the dedicated supplier quality authority, owning the full lifecycle of supplier qualification, auditing, monitoring, and performance management for a fast-growing medical device company. You'll wear multiple hats, partner cross-functionally, and have real influence in shaping how we manage suppliers as we scale.

What You'll Do

• Design, implement, and continuously improve our Supplier Quality Management Program — supplier qualification, controls, auditing, monitoring, and risk management
• Lead qualification and oversight of contract manufacturers, sterilization providers, and critical suppliers
• Plan, conduct, and report on supplier audits and assessments
• Own SCAR management from initiation through effectiveness verification
• Investigate supplier quality issues, drive root cause analysis and corrective action
• Build and maintain supplier scorecards, risk profiles, and performance metrics
• Partner cross-functionally with Engineering, Operations, Manufacturing, Supply Chain, and Regulatory Affairs
• Support FDA inspections, notified body audits, and customer audits
• Apply risk-based decision-making per ISO 14971

Required Experience

• 8-10+ years of Quality Assurance / Supplier Quality experience in the medical device industry
• Strong working knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, and ISO 14971
• Proven experience qualifying, auditing, and managing suppliers, including SCAR management
• Background in medical robotics, orthopedic implants, capital equipment, or electromechanical devices strongly preferred but not required
• Experience building a supplier quality program from scratch a big plus
• ASQ CQE, CSQP, CQA, or ISO 13485 Lead Auditor certification preferred
• Comfortable with up to 50% travel to our primary supplier located in South Bay

Logistics

• Onsite 3 days/week when not traveling to South Bay Supplier
• Full medical, dental, and vision; KPI-based bonus; stock options
• Please note: this role is not eligible for visa sponsorship, including TN visas