Principal Supplier Quality Engineer

THINK Surgical, Inc. • Fremont, CA

6d • $165,000 - $180,000 • Onsite

About The Position

The Principal Supplier Quality Engineer is the company’s technical leader and subject matter expert for supplier quality management. This position is responsible for developing, implementing, and continuously improving supplier quality systems and supplier performance programs to ensure the consistent delivery of conforming products and services throughout the supply chain. The Principal Supplier Quality Engineer leads complex supplier quality initiatives, drives supplier quality strategy, mentors quality professionals, and provides leadership in resolving high-risk supplier quality issues. This position plays a critical role in ensuring product quality, patient safety, supply continuity, and regulatory compliance. This position is based in the Fremont, CA office.

Requirements

• Bachelor's degree in Engineering, Science, or related discipline, or an equivalent experience.
• Minimum 8-10 years of Quality Assurance and/or Supplier Quality experience within the medical device industry.
• Strong working knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, and supplier control requirements.
• Demonstrated experience qualifying, monitoring, developing, and auditing suppliers.
• Demonstrated experience managing Supplier Corrective Action Requests (SCARs).
• Experience conducting investigations, root cause analysis, and corrective action activities.
• Experience with manufacturing processes, process validation, supplier controls, and quality system requirements.
• Strong analytical, organizational, and problem-solving skills.
• Strong written and verbal communication skills.
• Ability to independently manage multiple priorities and projects.
• Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.

Nice To Haves

• ASQ Certified Quality Engineer (CQE), Certified Supplier Quality Professional (CSQP), Certified Quality Auditor (CQA), or ISO 13485 Lead Auditor certification.
• Experience auditing contract manufacturers and critical suppliers.
• Experience with supplier quality management within medical robotics, orthopedic implants, capital equipment, or electromechanical devices.
• Experience supporting FDA inspections and notified body audits.
• Experience with supplier scorecards, KPI development, and quality data analytics.
• Experience with eQMS systems (e.g., Propel, MasterControl, Arena, etc.).

Responsibilities

• Lead the development, implementation, and continuous improvement of the company's Supplier Quality Management Program, including supplier management, supplier controls, supplier auditing, supplier monitoring, supplier risk management, and supplier performance processes.
• Evaluate existing supplier quality systems and implement improvements to harmonize supplier quality practices with FDA QMSR, ISO 13485, ISO 14971, and industry best practices.
• Manage supplier quality activities throughout the supplier lifecycle, including supplier qualification, monitoring, re-evaluation, development, and disqualification.
• Lead qualification and oversight of contract manufacturers, sterilization providers, critical suppliers, and other external providers.
• Plan, conduct, and report supplier audits and supplier assessments to evaluate compliance with quality system, regulatory, and contractual requirements.
• Establish and maintain supplier quality metrics, supplier scorecards, supplier risk profiles, and supplier performance monitoring programs.
• Investigate supplier-related quality issues and drive timely resolution through effective root cause analysis, corrective actions, and supplier engagement.
• Initiate, manage, and close Supplier Corrective Action Requests (SCARs) and monitor supplier effectiveness activities.
• Evaluate supplier nonconformances and determine appropriate containment, disposition, escalation, and risk mitigation activities.
• Support incoming inspection activities, supplier issue resolution, supplier change notifications, and supplier process validation activities, as required.
• Assess the impact of supplier changes on product quality, regulatory compliance, risk management documentation, and product performance.
• Partner cross-functionally with Engineering, Operations, Manufacturing, Supply Chain, Regulatory Affairs, and externals suppliers to ensure supplier quality requirements are effectively defined, implemented, maintained, and in compliance with FDA Quality Management System Regulation (21 CFR Part 820/QMSR), ISO 13485, ISO 14971, and other applicable regulatory requirements.
• Support new product development, sustaining engineering, supplier transfer, and supplier qualification activities.
• Develop and maintain supplier quality procedures, work instructions, forms, templates, and records.
• Support internal audits, notified body audits, customer audits, FDA inspections, and supplier-related regulatory activities.
• Support Management Review through supplier quality performance reporting, supplier risk reporting, and quality trend analysis.
• Provide technical leadership and subject matter expertise for supplier quality, supplier controls, supplier auditing, and supplier risk management activities.
• Mentor team members and promote adoption of best practices in supplier quality management.
• Apply risk-based decision making in accordance with ISO 14971 and company procedures.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal