**Job Type**: Full-Time Overview:We're SmileDirectClub, and we believe everyone deserves a smile they'll love. We also believe that you deserve a job you'll love. Good thing you found us, and we found you. At SmileDirectClub, we're all about empowering transformation. We want people to become more confident in how they look, how they feel, and how they think. So we're spreading smiles and positivity all over the country.It's no small task. That's why we're looking for energetic, passionate, and confident team members who can help turn frowns, into life-changing grins. Are you up for it?The Quality Systems Engineer I is responsible of supporting quality system implementation and improvements to ensure compliance with regulatory requirements including but not limited to CAPA (Corrective/Preventive) and Internal Quality Audit System. Prepare, analyze, and report quality system metrics to ensure quality system effectiveness.**Responsibilities**:**Responsibilities**:- Support the Corrective Action Preventive Action (CAPA) and Internal Quality Audit Systems.- Partner with CAPA owner to investigate issues related to, but not limited to, audit findings.- Support CAPA review board meetings as required.- Ensure CAPA and Audits records are following good documentation practices and procedure requirements.- Develop and conduct training related to the CAPA and Internal Quality Audit Systems to users as required.- Periodically prepare, analyze, and report quality system metrics to ensure quality system effectiveness as required.- Support the Change Control process.- Support audit activities as requested.- Conduct requested audits as scheduled.- Ensure compliance against standards and regulations of the areas that supports.- Complete assigned training on time.- Follow SOPs, internal policies, and requirements.- Perform investigation and take appropriate action as required.- Follow SOPs, internal policies, and requirements- Ability/flexibility to work in a fast-paced environment and technical level- Take the assigned portable computer home every day, to maintain connectivity to SDC and ability to perform required tasks offsite if required.Qualifications:**It will really make us smile if you have**- Bachelor's degree in Industrial Engineer or similar.- Experience: At least 1 year of related experience.- Previous experience working in a medical industry (FDA 21CFR part 820, ISO13485) environment is preferred.- Software: MS Office, Visio. SharePoint and statistical software are a plus.- Language: English / Spanish, (minimum Level B2).- CQE certification or equivalent is a plus.- Highly detailed-oriented with solid organization skills.- Problem solving skills.- Self-directed and motivated with ability to handle multiple tasks.- Ability to prioritize and adapt quickly to changing needs.- Oral and Written Communication.- Ability to write clear, concise, and comprehensive quality documentation.- Team player.- Ability/flexibility to work in a fast-paced environment at a technical level.- Action oriented- Nimble learning- Plans and synchronizes- Customer focus- Effective communicationCompany Profile:SmileDirectClub was founded on a simple belief: everyone deserves a smile they love. The Company is the first digital brand for straightening your smile, created after the realization that recent trends in 3D printing and telehealth could bring about disruptive change to the invisible aligner market by matching licensed professionals, a quality clear-aligner product, and customers together. By leveraging proprietary, cutting-edge technology, SmileDirectClub, LLC-affiliated dentists are providing greater access of care to consumers who couldn't otherwise afford orthodontic treatment to get a better smile.- What is SmileDirectClub? Link here.- What are our customers saying? Link here.- What is a SmileShop? Link here.- What is our culture like? Link here.- How do we celebrate your team members? Link here.
