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**Purpose**The incoming inspection coordinator is responsible for overseeing the incoming inspection process for materials and components used in Align Technology’s manufacturing operations. This role ensures that all inspection activities comply with applicable procedures, specifications, and regulatory requirements, including FDA GMP/QSR and ISO 13485. The coordinator leads the incoming inspection team, manages inspection-related projects, and ensures that materials are evaluated and accepted in accordance with pre-established inspection plans and quality standards.Key Responsibilities- Ensure all incoming inspection activities comply with ISO 13485, FDA 21 CFR Part 820, and other applicable global regulatory requirements (e.g., MDSAP)- Maintain effective communication with Align Mexico management regarding the status, performance, and outcomes of the incoming inspection process.- Define and monitor key performance indicators (KPIs) for the incoming inspection process; identify trends, failures, and opportunities for improvement.- Lead the development, implementation, and maintenance of procedures related to incoming inspection, ensuring alignment with current regulatory expectations.- Provide support to validate and identify measurement equipment and tools to support inspection activities across Align’s Mexico facilities.- Ensure that all incoming inspection personnel are properly trained and certified to perform inspections in accordance with component specifications and quality standards.- Oversee the acceptance and documentation of materials and components through designated inspection personnel.- Interpret Material Safety Data Sheets (MSDS) to establish appropriate handling, storage, emergency response, and waste management procedures for chemical materials.- Lead and manage inspection-related projects, including implementation of new inspection methods, equipment upgrades, and process improvements.- Coordinate cross-functional initiatives with R&D, Manufacturing sites, and Quality Engineering to ensure alignment on inspection requirements and execution.Skills, Knowledge & Expertise- Bachelor’s degree in Industrial Engineering, Electronics, Mechanical Engineering, or a related field.- Minimum of 6 years of experience in a quality engineering or inspection role, with strong knowledge of sampling plans and acceptance criteria.- Experience in project management or leading cross-functional initiatives is highly desirable.- Certifications such as Six Sigma or ASQ (CQE, CQT) are preferred.- Proficiency in Microsoft Office (Excel, Word, PowerPoint).- Valid Mexican visa and passport.- Willingness and availability to travel as needed.**Specific Language Requirements**:- **Advanced English proficiency** required (written and verbal), with the ability to communicate effectively across global teams and document technical procedures in English.About Align Technology**Your growth and well-being**:At Align, every smile matters. We’re committed to helping you thrive by supporting the health, growth, and well-being of our team members through a variety of tools and programs. While specific offerings may vary by location and role, Align employees can typically expect:- Health and well-being programs to keep you thriving in both body and mind.- Employee-exclusive discounts on Invisalign products.- Learning opportunities through online learning resources and support for your individual development plans.- Inclusive, global workplace that fosters collaboration, recognition and belonging.- Country and/or role specific details will be shared with you by your recruiter during the interview process.**Discover Align**:We are a global community of game-changers and smart team players, united by our belief in the power of a smile. Our dynamic team of exceptional employees is dedicated to transforming the industry and creating extraordinary outcomes every day.- Align’s core values of agility, customer, and accountability are more than words to work by, they are words we live by. The actions we take every day speak to who we are as a company and our focus on being truly impactful. We celebrate our differences, and the many ways we support one another— ultimately creating a more inclusive organization and world as we continue transforming smiles and changing lives.- We foster a culture where thinking differently and seeking new experiences are not just encouraged but celebrated. With the Align Mindset, we empower each other, ensuring every voice is heard and valued in an inclusive environment that inspires creativity and collaboration.- 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 w
