### **Description** Responsible for process improvement, identification of process control parameters, monitoring, and taking measures to prevent and/or correct issues with processes. Conducts technical investigations of customer complaints related to product and process issues. May conduct internal audits. Participates in customer complaint follow\-up and CAPA program investigations. Supports ongoing production activities and participates in the development of new technologies. Collaborates in the design and execution of process improvements and validations.### **Key Responsibilities** * Implement and maintain process controls and monitoring systems. * Develop testing and inspection methods. * Conduct validations of test methods, Gauge R\&R, etc. * Develop and implement real\-time, statistically\-based process control and system methodologies to eliminate reliance on product inspection and drive continuous improvement of product and quality processes. * Lead internal multidisciplinary teams based on process development and improvement efforts. * Coordinate risk assessment of new products and processes. * Conduct meetings and lead corrective and/or preventive action projects. * Document, define, measure, and improve current manufacturing processes using statistical process control techniques and methodology. * Ensure the use and application of the most appropriate manufacturing processes, techniques, and tools in terms of quality and productivity. * Investigate, develop, refine, and apply new trends, methods, and technologies in manufacturing processes. * Integrate and automate manufacturing systems and processes. * Continuously implement process improvement methodologies and techniques. * Establish robust process operation parameters to supervise and audit all processes, provide technical support to the manufacturing area and the development of new products. * Develop and conduct training courses on process, equipment, and create corresponding training material. * Optimize equipment utilization, determine and implement plant layout and material flow to optimize operations. Analyze, define, and implement material and equipment handling to improve operational profitability. ### **Skills, Knowledge \& Expertise** * Engineering studies. * Postgraduate studies (Desirable). * 7\-10 years of experience in mechanical or process engineering or related field (Desirable). * Experience in the medical or pharmaceutical industry regulated by the FDA (preferably). * Master Black Belt, Black or Green belt in Six Sigma (Desirable). * Preferably knowledgeable in the following areas: * ISO 13485 * JPAL (Japan Ministry of Health, Labor, and Welfare\- Ordinance No. 169, 2004\) * SOR/98\-282 (Canadian Medical Device Regulation) * MDD 93/42/EEC (European Council Directive) * U.S. Code of Federal Regulations **Specific language requirements** Intermediate 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 with the intent of changing millions of lives, one unique smile at a time. As part of our commitment to innovation, Align Technology includes exocad and Cubicure, companies that enhance our offerings and extend our impact to industry transformation. Eager to learn how we embrace our global differences and nurture employee well\-being? **Explore Align's culture here!** Want to discover more about **exocad** and **Cubicure**? Click on their names for additional information. **Applicant Privacy Policy:** Review our **Applicant Privacy Policy** for additional information. **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.