Supplier 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 This Sr. Supplier Quality Engineer role is responsible for managing supplier performance on quality of purchased parts per approved specifications. Qualifies and evaluates suppliers as part of onboarding process including periodical assessments such as supplier audits or periodical supplier evaluations.

Defines acceptance criteria like FAI, incoming inspection plans, etc.; drives conversations around supplier quality issues, monitor supplier corrective actions and fosters supplier continuous improvement. This position is also responsible for working with sourcing to develop new suppliers globally. In this role, you will… Establish and maintain supplier management process, ensure the process are comply with medical device regulatory requirements such as ISO 13485, cGMP and Medical Device Manufacturer Supplier Audit Guideline, etc.

Review supplier on boarding documentation ensure material is comply with relevant regulations/standards. Negotiate Quality agreements with suppliers as applicable. Lead supplier audits, issue audit report and supervise supplier’s correction, ensure supplier’s quality system meet Algin’s requirements. Evaluate qualified supplier’s performance, perform data analysis, trend judgment, risk pre-caution and mitigation, and report to management. Work with sourcing to control supplier change process, ensure the process is comply with Align’s QMS requirements.

Work with engineering for supplier qualification, lead FAI process & define incoming quality acceptance criteria. Lead supplier quality issues by handling material non-conformities, monitoring supplier corrective actions, and driving supplier continuous improvement. Work with global/local sourcing to develop new supplier globally and supplier localization Support external audit processes related to supplier issues. In this role, you’ll need … Bachelor’s degree or above in Engineering / Science fields.

Minimum 6+ years work experience in supplier quality control, experience in medical device manufacturing industry is preferred. Knowledge of quality tools methods & implementation, familiar quality management system and medical device regulations are preferred. Analytical skills, attention to detail and ability to communicate issues and solve problems. Ability to work on multiple projects in a fast-paced environment. Good communication skills with suppliers and local/global co-workers.

Computer skills including Word, Excel, PP, etc. Travel domestically and internationally 10-15% of the time Sound like a good fit? Great! Click the "Apply" link to let us know you are interested. Not the right fit? Don’t worry, Align is quickly growing so we are creating more opportunities to expand our Align family. Please consider joining our Talent Network to receive notifications about future jobs or sharing this opportunity with others in your network.

About Align Align Technology is a publicly traded medical device company that is transforming smiles and changing lives. Our global team of talented employees develop innovative technology, tools and treatment options to help dental professionals worldwide achieve the clinical results they expect. Our digital ecosystem combines the power of technology to create beautiful smiles through the integration of AI and machine learning, digital imaging and visualization, biomechanics and material science to develop the Invisalign system, the most advanced clear aligner system in the world;

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