Sr. Production and Suppliers Quality Engineer

Join a team that is changing millions of lives. Transforming smiles, changing lives   At Align Technology, we believe a great smile can transform a person’s life, so we create technology that gives people the confidence to take on whatever’s next. We revolutionized the orthodontic industry with the introduction of the Invisalign system, and we have never lost sight of that spirit of innovation. Our diverse and collaborative teams are constantly pushing the boundaries of what’s possible.   Ready to join us?  About this opportunity The Sr. Production and Supplier Quality Engineer is responsible for driving exceptional product quality for the patient safety, customer value beyond expectations, regulatory assurance, and optimized Cost of Quality for Align. This is a key technical position, affecting part quality for both installed base and NPI parts. In this role, you will… Improve supplier quality performance for assigned suppliers. Lead supplier audits as required by Align supplier audit schedule and supplier performance management requirements Perform supplier qualification processes - including quality requirements definition & communication, control plan negotiation, COT definition, etc… Participate in supplier selection process and specification reviews with suppliers to ensure that purchased components/materials meet Align specifications Assure supplier compliance to Align QMS and regulatory requirements through supplier monitoring process. Ongoing supplier’s evaluation & monitoring – source inspections, statistical analysis. Specify quality characteristics and inspection plans for components, subassemblies, and finished devices Develop positive relationships and work closely with Sourcing Leaders to manage and implement supplier/engineering changes, New Product Introductions, and transfers. Lead and collaborate with cross-functional teams to manage supplier change notifications through risk based evaluation Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested Interface with Suppliers, Engineering, Service, Manufacturing and Sourcing to drive Quality improvements that minimize the Costs of Quality, specifically Failed on Arrival/Install (DOA/RMA) issues, Field Failures, and Factory defects. Assure Corrective and Preventive Action plans are developed and executed at assigned suppliers in compliance with the CAPA process. In this role, you’ll need … Fundamental knowledge of ISO13485:2016 and FDA requirements for medical device industry Effective problem solving, root-cause analytical skills to lead and influence others to drive change (cross-functionally and globally). Ability to work independently with minimal supervision Computer skills (Microsoft Word, Excel, PowerPoint) Working knowledge in Statistical Tools (Measurement Systems Analysis, Process Capability and Statistical Process Control)- preferred Knowledge of various quality system methodologies Lean, 5 Why’s, DFMEA, PFEMA, PPAP, etc.- preferred Strong written and verbal communication skills in English Strong organizational skills Bachelor's Degree in an engineering or equivalent applicable experience 7 years of experience in production and supplier quality engineering in medical device industry or highly regulated industry Sound like a good fit?      Great! Click the