The QARA Sr. Director is an experienced, hands on professional within the medical device industry with extensive knowledge performing their function within the Food & Drug Administration (FDA) Quality System Regulation (QSR); International Organization of Standardization (ISO) 13485 & 14971; Medical Device Directive (MDD) 93/42/EEC; Canadian Medical Device requirements; Japan’s pharmaceutical Affairs Law (JPAL); and any other applicable worldwide regulatory requirement and business needs (e.g. HIPAA).

The incumbent has the ability to take strategic direction and establish efficient and compliant processes throughout the organization and has strong communication at all levels. This position is to manage the Quality Assurance team members to include incoming inspection, quality assurance, quality compliance, and quality engineering, as well as Regulatory Affairs.

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?