Senior Supplier Quality Engineer - Lead Quality Programs

THINK Surgical, Inc.; Fremont (CA); On-site; USD 165,000 - 180,000; Full time

Job summary

THINK Surgical, Inc. in Fremont, CA is seeking a Principal Supplier Quality Engineer to lead supplier quality management across the supply chain. You will develop and implement programs ensuring conforming products, patient safety, and regulatory compliance.

You will mentor quality professionals, drive supplier quality strategy, and oversee audits, SCARs, and supplier risk management while partnering with cross-functional teams to meet regulatory requirements.

Qualifications

• Minimum 8–10 years of Quality Assurance and/or Supplier Quality experience in the medical device industry.
• Bachelor's degree in Engineering, Science, or related discipline.
• 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.
• Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.

Responsibilities

• Lead the development, implementation, and continuous improvement of the company's Supplier Quality Management Program.
• 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.

Skills

Quality Assurance

Supplier Quality

Regulatory knowledge

Root cause analysis

Auditing

Project management

Education

Bachelor's degree in Engineering, Science, or related discipline

Tools

Propel eQMS

MasterControl eQMS

Arena eQMS

Job description

THINK Surgical, Inc. in Fremont, CA is seeking a Principal Supplier Quality Engineer to lead supplier quality management across the supply chain. You will develop and implement programs ensuring conforming products, patient safety, and regulatory compliance.

You will mentor quality professionals, drive supplier quality strategy, and oversee audits, SCARs, and supplier risk management while partnering with cross-functional teams to meet regulatory requirements.