Support production quality and supplier performance for medical devices by controlling ATE testers, driving ECO/ECR and NPI changes, performing supplier audits, leading RCA/CAPA/NCR activities, and ensuring compliance with ISO 13485, FDA 21 CFR 820, and ISO 14971 to reduce field failures and improve reliability.
About this opportunity
We are seeking a highly motivated and experienced Production and Suppliers Quality Engineer to drive exceptional product quality, patient safety, and field reliability across the Installed Base (IB). This is a key technical role supporting production stability, RMA/DOA investigations, Automated Test Equipment (ATE) performance, and cross-functional quality engineering initiatives in a regulated medical device environment.
Key Responsibilities
In this role, you will:
• Support qualifications and control of ATE testers in V&V phase and production lines.
• Support ECO/ECR processes, NPI projects, product updates, and cross-functional engineering changes.
• Participate in supplier selection and conduct suppliers’ audits
• Work closely with R&D, engineering, manufacturing, and operations teams to enhance product quality
and resolve technical issues.
• Drive continuous improvement initiatives using tools such as Six Sigma, Lean, and Root Cause Analysis (RCA).
•. Support RMA/DOA processes and continuous reduction of field failures
• Ensure compliance with ISO 13485, FDA 21 CFR 820, MDR, and other applicable medical device regulations.
• Maintain and support quality documentation, including CAPA, Non-Conformance Reports (NCRs), and risk management documentation.
Skills, Knowledge & Expertise
• Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical, or related field).
• 3+ years of experience in Quality, medical device experience is a strong advantage.
• Strong analytical and problem-solving skills, including hands-on experience with RCA tools (5-Why, Fishbone, etc.).
• Familiarity with ATE systems, production testing, and/or field reliability analysis — a strong advantage.
• Working knowledge of ISO 13485, FDA 21 CFR 820, and ISO 14971 risk management.
• Excellent communication and collaboration skills, with the ability to work effectively across functions.
• A proactive, structured, and detail-oriented working style.
• Fluent in English.
About
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.
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