Quality Specialist

Product Lehi, Utah Santa Monica, California


Description

About byte.

We are an ambitious team that's transforming the way people achieve a beautiful, more confident smile. No longer do you have to step inside the orthodontist office to create the smile of your dreams.  With a click of a button, you are on the road to making those dreams a reality. Our doctor-directed, at-home system makes it easy, safe and affordable for everyone.

We also believe that a job should do more than pay the bills. It should fill you with a sense of purpose. The kind you feel when you’re a part of something BIG. 

Interested? Let’s talk.

The Quality Specialist position is responsible for supporting the activities of byte Quality Management System. Under general direction, this position is responsible for guiding and supporting the various aspects of the Quality Assurance and Regulatory Compliance systems. A person in this position will ensure compliance with procedures and guidelines to satisfy FDA/GMP/ISO regulations concerning the coordinating, handling and documentation of quality system elements as assigned. The assigned quality system could include: Learning Management System, complaints, document control, CAPA, Non-conformances, change control, supplier quality, training or internal auditing.

Job Responsibilities

  • Ensures compliance to relevant corporate compliance SOP’s, byte procedures, location SOPs, location work Instructions
  • and national and international standards, 21CFR820 and ISO13485.
  • · Prepares quality system reports as assigned to management.
  • · Provides support to the QA/RC team with respect to the execution and maintenance of the assigned Quality System.
  • · Carry out special assignments / projects in broad areas upon request of QA/RC management
  • · Participate in both internal and external audits (including but not limited to Notified Body, FDA, etc.)

Key Qualifications

  • Associate’s degree (A.A) or equivalent from two-year college or technical school; or six months to one year related experience and/or training; or equivalent combination of education and experience.
  • Understanding of FDA Quality System Regulation, with ISO 13485 preferred.
  • Good oral and written communication skills are required and ability to work with all levels of an organization.
  • Good organizational skills, including attention-to-detail and appreciation of deadlines.
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • Computer skills include, but are not limited to: Microsoft Office programs including PowerPoint, Excel, and Word · Microsoft SharePoint · Microsoft Teams

The Perks.

  • Competitive pay PLUS employer paid contribution toward company sponsored health care plan.
  • Unlimited vacation policy!
  • We’ll hook you up with awesome aligner and whitening benefits. Your family too!
  • An exceptional company culture (if we do say so!) in a truly flat organization that values commitment and hustle over titles and rigid hierarchies.
  • The opportunity to be part of a fast paced, hyper growth company with amazing career growth potential!