What are the responsibilities and job description for the Supplier Quality Manager position at Align Technology?
Department: Quality
Location: US-North Carolina-Raleigh
Description
This 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
Review our Applicant Privacy Policies for additional information.
Global Diversity Statement
At Align, we believe in the power of a smile, and we know that every smile is as unique as our employees. As we grow, we are committed to building a workforce rich in diverse cultural backgrounds and life experiences, fostering a culture of open-mindedness and compassion. We live our company values by promoting healthy people and healthy communities, all with the intent of changing millions of lives, one unique smile at a time.
Equal Opportunity Statement
Align Technology is an equal opportunity employer. We are committed to providing equal employment opportunities in all our practices, without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity or expression, or any other legally protected category. Applicants must be legally authorized to work in the country for which they are applying, and employment eligibility will be verified as a condition of hire.
Location: US-North Carolina-Raleigh
Description
This 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.
- 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.
Review our Applicant Privacy Policies for additional information.
Global Diversity Statement
At Align, we believe in the power of a smile, and we know that every smile is as unique as our employees. As we grow, we are committed to building a workforce rich in diverse cultural backgrounds and life experiences, fostering a culture of open-mindedness and compassion. We live our company values by promoting healthy people and healthy communities, all with the intent of changing millions of lives, one unique smile at a time.
Equal Opportunity Statement
Align Technology is an equal opportunity employer. We are committed to providing equal employment opportunities in all our practices, without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity or expression, or any other legally protected category. Applicants must be legally authorized to work in the country for which they are applying, and employment eligibility will be verified as a condition of hire.
