Lead Supplier Quality Engineer - Build QMS from Scratch

BioTalent Ltd; Fremont (CA); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Full medical, dental, and vision

KPI-based bonus

Stock options

Job summary

BioTalent Ltd is seeking a Principal Supplier Quality Engineer in Fremont, CA to build and own the supplier quality program from the ground up. The role is onsite 3x/week with up to 50% travel to the South Bay supplier network in a fast-growing medical device company.

You will lead audits, SCAR management, and cross-functional collaboration with Engineering, Operations, and Regulatory Affairs to ensure robust supplier performance and regulatory compliance.

Qualifications

• 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 preferred.
• 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.

Responsibilities

• 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

Skills

Quality Assurance

Supplier Quality

Auditing

SCAR management

FDA 21 CFR Part 820

ISO 13485

ISO 14971

ASQ CQE/CSQP/CQA

Regulatory knowledge

Job description

BioTalent Ltd is seeking a Principal Supplier Quality Engineer in Fremont, CA to build and own the supplier quality program from the ground up. The role is onsite 3x/week with up to 50% travel to the South Bay supplier network in a fast-growing medical device company.

You will lead audits, SCAR management, and cross-functional collaboration with Engineering, Operations, and Regulatory Affairs to ensure robust supplier performance and regulatory compliance.