Director, Global Quality Systems

  • Align Technology
  • Rotkreuz ZG, Switzerland
  • 13/07/2020
Full time Data Science Data Analytics Big Data Statistics

Job Description

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 opportunityBuild and improve globally harmonized quality management system (QMS) for all of Align technology locations globally. Design and implement strategy for quality certifications and interfaces among entities. Create visibility and accountability for QMS process indicators for all sites and reporting to executive management. Leverage global Quality leadership team in sharing best practices and coordinating global efforts. Lead evaluation of best in class processes and tools. Oversee implementation of QMS process tools such as electronic document control, change control, and CAPA solutions to leverage the buying power of a global entity. Coordinate and streamline site-to-site interfaces including change control and design transfer activities. This person must establish effective partnerships within and outside of the quality team to facilitate the timely identification and resolution of quality matters as well as opportunities for quality process improvement.
In this role, you will…

  • Lead Quality Management System harmonization activities from policy to execution 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.
  • Formulate and manage an improvement program to increase the maturity level of Align’s current quality management systems globally.
  • Coordinate global corporate quality system activities for transparent and consistent reporting of QMS processes such as: corrective and preventive action, internal auditing, risk management, validation, etc.
  • Evaluate interactions, handoffs and dependencies among QMS-es, sites, and departments in the support of a true quality system that is designed to work cohesively for the reliable production of the highest quality products and services.
  • 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.

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 and training. Proven ability to drive harmonization globally for efficiency of quality operations.
  • 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.
  • Must interact well with all levels of management, co-workers, and regulators.
  • Must possess strong written, verbal and interpersonal communication skills and work independently as well as in close collaboration with others.
  • BS in Management, Engineering or Science preferred.
  • 10 + years in a lead Quality role at a medical device company (15+ for Sr. Director).
  • Experience in quality manufacturing role at a medical device company
  • Global Quality experience at a medical device company including supporting markets in Asia Pacific, Greater China and Russia.
  • Extensive experience interfacing with FDA/international regulatory agencies as well as ISO notified bodies.
  • Software-related quality (SaMD, SiMD) and regulatory experience is a must.
  • Certified Lead Auditor for performing internal quality system audits.

Sound like a good fit?
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About Align
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.