Join a team that is transforming smiles, changing lives.
At?Align Technology, we believe a great smile can truly 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 teams are constantly pushing the boundaries of what’s possible.
Ready to join us??
About this opportunity
Lead the Quality Management System for the San Jose CA site. Lead team of Quality Engineers in support of product development teams. Partner in optimizing, streamlining, and increasing compliance with design control requirements for products designed in San Jose. Products include materials-based products (aligners, retainers, accessories) and treatment planning software systems (SaMD). Maintain the site QMS in conformance with the multi-site ISO 13485 certificate. Partner with other site QA leaders to globally harmonize the QMS and clarify interfaces among Align sites.
In this role, you will…
• Lead team of QA and QE resources including employee goals setting, org development, performance management and training needs assessment.
• Lead Quality Management System activities to ensure compliance with 21 CFR Part 820, ISO 13485, MDSAP and all applicable worldwide regulatory requirements as included in the scope of Align’s Quality Manual.
• Lead effort to transform design control and design change processes for San Jose design center which include multiple types of SaMD and non-device software systems (Medical device data systems, business systems).
• Collaborate with operations sites to clarify design transfer process and change requests from the manufacturing facilities back to the design center.
• Proactively collaborate on assessment of site to site interactions, handoffs and dependencies among QMS-es.
• Establish key quality system metrics and develop collection, analysis, and reporting systems, which promote timely communication and corrective action.
• Escalate nonconformities in the Quality System to upper management where appropriate.
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Align Technology is a publicly traded medical device company that is changing lives through better smiles. 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.
Align Technology is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We also respect your privacy. Please review our Applicant Privacy Policies for additional information.
In this role, you’ll need…
Candidate must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
In depth knowledge of the Quality System Regulation (QSR), ISO 13485, MDSAP, and EU Medical Device Regulation.
High level of knowledge of all QMS sub systems including: CAPA, internal audits, risk management, design control, verification and validation, internal and external audits, management responsibility, training.
Experience leading a quality organization in a medical device company which includes software as a medical device products
Demonstrated leadership through influence as well as direct line reporting structures. Must be able to communicate globally and create followership.
Must be able to thrive in a fast-paced environment with ever-changing business objectives, be willing to adapt to change, as well as being capable of driving change.
Ability to manage direct staff for optimal performance, coach as needed and raise the bar
Must interact well with all levels of management, co-workers, and direct reports.
Must possess strong written, verbal and interpersonal communication skills and work independently as well as in close collaboration with others.
Education and Experience:
BS in Management, Engineering or Science preferred.
5 + years in a lead Quality role at a medical device company
Experience in quality leadership role at a medical device company, experience with SaMD products and materials based products Software-related quality (SaMD, SiMD) experience is a must.
Extensive experience interfacing with FDA/international regulatory agencies as well as ISO notified bodies.
Certified Lead Auditor for performing internal quality system audits.
About Align Technology
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 teams are constantly pushing the boundaries of what’s possible.