SmileDirectClub is a growing company that’s revolutionizing the invisible aligner market. By connecting patients and providers in the digital space (B2C), we can make beautiful smiles more affordable for everyone. We provide direct-to-patient invisible aligner treatment that allows patients to realign their smile affordably, conveniently and privately from home.
 

SmileDirectClub is looking for a highly motivated, hands-on, results-oriented Director of Quality Management Systems (QMS). The Director of QMS is responsible for driving quality excellence throughout the organization by providing overall strategic direction and guidance for the quality system and regulatory compliance. You will ensure that medical products and devices (Class I and II) are compliant with all FDA regulations. This highly motivated individual will be responsible for overall management of practices and procedures to achieve deliverables in quality and compliance. You will also be responsible for overseeing Quality Assurance and Regulatory Affairs by directing and coordinating activities consistent with established company goals, objectives, FDA Quality System Regulations.
 

Responsibilities:
 

• Promote the development of a company-wide culture of quality excellence and understanding of key elements related to quality system and regulatory compliance.
• Improve, maintain, and execute early stage quality system for a dental device company.
• Oversee design assurance and drive the design control (DHF) and risk management processes (CAPA), including developing quality & risk management plans & reports; conducting hazard analysis, DFMEA, PFMEA, etc.; and authoring verification and validation protocols and reports.
• Develop test methods and inspection procedures and implement process control systems to support the development, qualification, and on-going manufacturing of products.
• Lead supplier quality management and conducting supplier performance reviews and audits.
• Serve as the management representative for regulatory agencies.
• Maintain knowledge of existing and emerging regulations, standards, or guidance documents. Interpret regulatory rules or rule changes and ensure that they are communicated throughout corporate policies and procedures. Evaluate and develop Quality Agreements and strong partnerships with suppliers
• Develop and enhance key elements of the quality system including continuous improvement using CAPA and quality documentation
• Drive continuous improvement and proactively identify and implement best-in-class quality engineering practices.
• Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
• Proactively investigate and analyze customer complaints, and oversee problem reporting.
• Coach and develop team members and supervise/train quality technicians.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
• Develop strategies, KPI’s and written business policies aligned with organizational goals and regulations.

Qualifications:
 

The successful candidate must be a highly motivated and organized individual, with the capacity to perform in a dynamic environment. The Director of QA and Compliance must also possess the following skill set:

• Natural leader focused on results as their #1 priority - always seeking out better ways to ensure Company and team’s success.
• BS degree or higher in Engineering, Science, Technology or related field.
• Several years experience in medical device manufacturing with multi-years in a management position.
• Experience developing and implementing Quality Management Systems (QMS).
• Extensive knowledge of medical device regulations including FDA and ISO standards. Extremely helpful to have familiarity with concepts like DHF.
• Experience in dealing with complex product issues and working across multiple functions and locations to meet requirements and goals.
• ASQ Certified Auditor or equivalent.
• Solid communication and interpersonal skills.
• Strong project management and leadership skills with the capability to motivate teams to achieve results in a fast-paced, growing business.
• Must have demonstrated ability to increase efficiencies and key performance measures. Ability to travel approximately up to 20%.

SmileDirectClub is changing orthodontics one smile at a time. The company provides consumers with custom invisible aligners for use at home which gradually shift teeth into their desired position for a brighter, straighter smile.

We are shaking up an industry, building a fast company and crafting a culture of collaboration, experimentation, and reaching stretch goals. 
We are entrepreneurs and we’re led by market disrupting executives and backed by investors, Camelot Venture Group, who have remade industries with innovative companies such as 1800 Contacts, Quicken Loans, Fathead, Songbird Hearing and The Sharper Image. We’re doing it again. This time, you can be a part of it.