Sr. Quality Engineering Manager

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 Align Quality Engineering team is looking for a Senior Quality Engineering Manager to join us in Raleigh, NC or Austin, TX. In this role you will partnering directly with Engineering, Product, and Regulatory and Quality teams to help Align ensure its compliance to new and existing regulations and guidance. You will examine our current procedures and determine how to strengths and simplify to ensure understanding and compliance. You will work together with fellow leaders, and peer stakeholders to help redesign our SDLC tool stack to continually develop and improve the SDLC and related Quality Engineering processes while helping to ensure Engineering teams remain compliant with standards. You will work with Engineering Quality Center of Excellence (QCOE) team members to help create automated processes to support our movement to a push-button deployment model. As a Senior Quality Engineering Manager, you will need experience working within an Influence Without Authority model as you partner with leaders around the globe without direct reports. Being part of the QCOE is a unique opportunity to help drive a culture of open decisions, inner sourced code, and other high-visibility targets. You will be seen as a thought leader in the space and will be required to demonstrate your leadership skills to help bring innovative solutions to complex problems. This is an exclusive role with a large amount of organizational exposure. In this role, you will… Be an expert in software development methodologies. Working knowledge of associated standards (62304, 82304, 81001...). Review and strength compliance to industry standards and guidance for development and maintenance of Software as Medical Device (62304, 82304, 81001, AI/ML guidance). Aid in the simplification and harmonization of Compliance and Quality documentation. Collaboratively develop new procedures to properly handle compliance with new and emerging technologies (such as AI/ML). Champion a harmonized Quality Management approach across the company, ensuring consistency in implementation and standardization of processes. Evolve methodology in response to feedback from RA/QA & Engineering regarding compliance, efficiency & feasibility. Support the rebuild of SDLC tool stack utilizing Atlassian tools infrastructure (JIRA, Bamboo, Confluence, etc.) and other tools such as Aligned Elements (Requirements Management) and Zephyr Scale to enable built in quality and compliance of regulations in engineering practices. Learn, Grow, and Maintain Quality Engineering’s strategy, ensuring alignment of the offering with team and larger business strategy and priorities. Participate and promote a culture of collaboration, agility, and ownership within and across teams. In this role, you’ll need … 12+ years of experience with Design Quality or Quality Engineering in Medical Device development Strong understanding of industry regulations such as ISO 13485, IEC 62304, and IEC 82304 Solid knowledge of SDLC combined with practical experience working in agile teams. Experience in development of SOP, WI in a modern software development ecosystem. Proved and tested ability to communicate effectively throughout all levels within a company and with those from diverse cultural background. Ability to balance tasks, prioritize, and work well within pressured environment while also maintaining a level of self-autonomy. Experience in Software Quality Assurance or Development a plus. 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; iTero Intraoral Scanners and OrthoCAD digital services. Did you know? Align is the world’s largest manufacturer of custom 3D-printed materials. By joining Align, you will be part of a global, fast-growing company in one of the most dynamic industries. Great people, innovative technologies, and meaningful work – these are just some of the things employees say make Align Technology a great place to work. We respect your privacy. Please review our Applicant Privacy Policies for additional information. Global Diversity Statement: 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 will continue building a workforce of diverse cultural backgrounds and life experiences and fostering a culture of open-mindedness and compassion for all our employees. 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. Equal Opportunity Statement It is our policy to provide equal employment opportunity in all of our employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Align must be legally authorized to work in the country which they are applying for and verification of employment eligibility will be required as a condition of hire. About the company

Align Technology is a manufacturer of 3D digital scanners and the Invisalign clear aligners used in orthodontics. Notice

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