Principal Supplier Quality Engineer

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.

DUTIES & 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 compliancewith 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.

SUPERVISORY RESPONSIBILITIES

N/A

QUALIFICATIONS

Required 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. Preferred 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.).

COMPETENCIES

Drive results Problem solving and root cause analysis Strategic thinking Technical leadership Risk-based thinking Process improvement Project leadership Effective communication and collaboration Business acumen

PHYSICAL DEMANDS & WORK ENVIRONMENT

Must be able to remain in a stationary position and operate office equipment for a prolonged period of time. Physical activities include, but not limited to constant manual dexterity, moving about the work site, and/or handling objects weighing up to 20 lbs. Other infrequent physical activities include, but not limited to, positioning self to complete assigned tasks, and ascending/descending floors and/or ladders. Occasionally work around moving mechanical parts. Must be able to work in a schedule that commensurate with business operation, including work during weekends, holidays and/or times outside of normal business hours. Must be able to travel as business necessitates (up to 50%). Disclaimer The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be possible to enable individuals with disabilities to perform the essential functions. THINK Surgical, Inc. (“THINK”) is committed to hiring the best qualified candidates for approved positions while engaging in recruitment and selection practices that are in compliance with all applicable employment laws. It is the policy of THINK to provide equal employment opportunity for employment to all applicants and employees, regardless of any protected status. Any qualified applicant or employee with a disability who requires an accommodation in connection with their employment at THINK should contact Human Resources and request an accommodation. THINK also participates in E-Verify, a web-based system that allows THINK to confirm an employee’s eligibility to work in the United States. Actual compensation offered will depend on several factors including but not limited to geographic location, work experience, education, skill level, and/or other business and organizational needs. #J-18808-Ljbffr THINK Surgical