Sr. Supplier Quality Engineer

This Sr. Supplier Quality Engineer role is responsible for managing supplier performance on quality of purchased parts per approved specifications. Qualifies and evaluates suppliers as part of onboarding process including periodical assessments such as supplier audits or periodical supplier evaluations.

Defines acceptance criteria like FAI, incoming inspection plans, etc.; drives conversations around supplier quality issues, monitor supplier corrective actions and fosters supplier continuous improvement. This position is also responsible for working with sourcing to develop new suppliers globally.

• Establish and maintain supplier management process, ensure the process are comply with medical device regulatory requirements such as ISO 13485, cGMP and Medical Device Manufacturer Supplier Audit Guideline, etc.
• Review supplier on boarding documentation ensure material is comply with relevant regulations/standards.
• Negotiate Quality agreements with suppliers as applicable.
• Lead supplier audits, issue audit report and supervise supplier’s correction, ensure supplier’s quality system meet Algin’s requirements.
• Evaluate qualified supplier’s performance, perform data analysis, trend judgment, risk pre-caution and mitigation, and report to management.
• Work with sourcing to control supplier change process, ensure the process is comply with Align’s QMS requirements.
• Work with engineering for supplier qualification, lead FAI process & define incoming quality acceptance criteria.
• Lead supplier quality issues by handling material non-conformities, monitoring supplier corrective actions, and driving supplier continuous improvement.
• Work with global/local sourcing to develop new supplier globally and supplier localization
• Support external audit processes related to supplier issues.

• Bachelor’s degree or above in Engineering / Science fields.
• Minimum 6+ years work experience in supplier quality control, experience in medical device manufacturing industry is preferred.
• Knowledge of quality tools methods & implementation, familiar quality management system and medical device regulations are preferred.
• Analytical skills, attention to detail and ability to communicate issues and solve problems.
• Ability to work on multiple projects in a fast-paced environment.
• Good communication skills with suppliers and local/global co-workers.
• Computer skills including Word, Excel, PP, etc.
• Travel domestically and internationally 10-15% of the time

Primary Location Base Salary Range: $140,600 to $162,700 USD


Base salary ranges are a guideline used to determine appropriate pay. Placement depends on the individual skills and experience level of a candidate plus the total compensation and equity across team members. For other locations outside of the primary location, the base salary range will be adjusted geographically. For field Sales roles, the salary listed is the base pay only and does not include the applicable commission plan. A cost of living adjustment may be added to base pay for higher cost areas in the U.S. Our internship hourly rates are a standard pay determined based on the position and your location, year in school, degree, and experience.