Supplier Quality Manager

Job DescriptionJob DescriptionDescriptionThis position is ideal for mid-level Supplier Quality leaders to join the Invisalign Quality team as a Manager, Invisalign Supplier Quality, driving standardization of supplier management practices across globally dispersed operations facilities and design facilities. Partnering with cross-functional teams including Supply Chain, R&D, Quality, and Regulatory, you’ll help develop meaningful business relationships with critical suppliers, review supplier manufacturing processes and collaborate with suppliers on process improvement and value enhancement opportunities. This role is vital in shaping Invisalign’s supplier management and product quality.

Role expectations

• Develop and own a robust supplier quality lifecycle management strategy, including procedures and work instructions, beginning with supplier selection through deactivation; including supplier qualification, classification, quality agreements, audits, continuous performance evaluation, and second sourcing recommendations for key vendors.
• Create and implement supplier monitoring metrics including supplier performance monitoring/scorecards to ensure supplier’s ability to meet Align’s quality standards 
• Work closely with Supply Chain team to define robust supplier processes that support the business relationships between Align and its suppliers in an efficient manner. Collaborate in the selection, qualification, performance management, and disengagement processes for suppliers.
• Responsible for oversight and development of supplier corrective action process (SCAR); participate in investigations with suppliers as necessary and monitor execution of corrective actions.
• Responsible for oversight of the Align approved supplier list (ASL)., 
• Establish and maintain supplier audit schedule, perform audits as needed, report outcomes, metrics, and follow up with all suppliers. Establish escalation process for poorly performing suppliers
• Develop a process for review and approval/qualification of supplier-initiated changes (SCN process)
• Act as global coordinator for supplier quality at all Invisalign locations.  Ensure consistency of approach and implementation of supplier quality controls.  Partner with global eQMS team to enhance and develop electronic systems for support of the function.
• Willing to travel 10-25%

What we're looking for

• Education: Bachelor’s degree in Engineering, Quality, or a related field; advanced degree .
• Experience: Minimum of 6-8 years of experience in supplier quality engineering, with at least 3-5 years in a leadership role within the medical device industry
• In-depth knowledge of ISO 13485, FDA QSR, and EU MDR requirements.
• Proven experience in supplier auditing, risk management, and CAPA.
• ASQ Certified Quality Engineer (CQE) or Lead Auditor certification is a plus.
• Communication: Strong leadership, communication, and interpersonal skills.
• Teamwork: Ability to work effectively in a cross-functional team environment.