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AlignTech Supplier Quality Manager United States, North Carolina, Raleigh 856894387
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- Employment Type
- Full Time
- US-North Carolina-Raleigh
- Workplace type
- 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%
- Education: Bachelor’s degree in Engineering, Quality, or a related field; advanced degree preferred.
- 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.
Your growth and well-being:
- Health and well-being programs to keep you thriving in both body and mind.
- Employee discounts on Invisalign products.
- Learning opportunities though online learning resources and support for your individual development plans.
- Inclusive workspace that fosters diversity and collaboration.
Country-specific details will be shared with you by your recruiter during the interview process.
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