Sr. Quality Systems 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 Sr. Quality Systems Manager is an experienced, hands-on professional within the medical device industry with extensive knowledge of the requirements of FDA Quality System Regulation (QSR); ISO 13485 & 14971; and applicable worldwide regulations (e.g. EU-MDR, China, Japan, Brazil, etc.)

The individual exercises independent judgment in establishing Quality System methods, techniques and evaluation criteria for meeting quality objectives. The Sr. QA Manager sets strategic direction, establishes efficient and compliant processes throughout the organization and has strong communication skills at all levels. This position will manage implementation of the corporate QMS locally and provide quality oversight to functional teams located at the site.

This position will be located in either the San Jose, CA or Raleigh, NC HQ office. In this role, you will… Audit and perform gap assessments on remote site Quality Management Systems Develop Quality plans for integration of new entities into the Align QMS Onboard entities as critical subcontractors under Align QMS Assist in development of Quality Agreements Assist in maintenance of an ISO 13485:2016, EU MDD/MDR, FDA 21 CFR Part 820, compliant Site Quality Management System Mange and implement new quality initiatives within the site including the implementation of Corporate Policies and Procedures Guide functional & cross-functional teams in the definition of core quality system processes Conduct Quality Systems audits and assist in training/guidance to other auditors Assist with preparation and hosting of external Quality System inspections Fluent in computer skills and, at a minimum, the use of Microsoft Office Word, Microsoft Office Excel, Microsoft Office PowerPoint and Microsoft Office Project In this role, you’ll need … Bachelor’s degree in Engineering discipline or equivalent 10+ years experience with Quality Management Systems ISO 13485 and MDSAP experience Familiar with ISO 62304, Medical Device Software – Software Life Cycle processes Knowledge of US and International laws and standards that apply to the medical device industry including FDA Quality Systems Regulations, ISO 13485, MDD, EU MDR/IVDR, Canadian MDR, Japan PMDA as well as ANVISA requirements Software as A Medical Device (SaMD) experience, as well as Device History Record requirements for SaMD.

Creative problem-solving skills with exceptional verbal and written communication skills, and the ability to mentor others in Quality Management Systems 6+ years of experience in medical device environment Ability to organize and judge priorities in a dynamic, fast-paced environment and work independently with minimal supervision Ability to travel occasionally (>10%) Desired Skills…

Experience with hosting FDA and ISO 13485 Certification audits/inspections is a plus Ability to speak German is 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…