LightForce Ortho

Position

Quality Manager

Location

Onsite at HQ in Burlington, MA

About LightForce

LightForce is a 3D printing technology company focused on the orthodontic space. Our digital platform empowers orthodontists with fully customized, 3D-printed tooth-moving tools. In 2019, we launched our first product - the world’s only, fully customized 3D printed bracket system and digital treatment software. We are proud to be one of the fastest growing companies in the industry. Learn more at: www.lf.co

Description

We are looking for a Quality Manager to join our Physical Manufacturing Team at LightForce. We are seeking a talented and enthusiastic hands-on Manager to lead on a multitude of quality projects, from analytical quality analysis to quality performance testing, suppliers quality, defining the quality standards and protocols to enable meaningful scale, while maintaining and improving the quality of our products and processes. Our ideal teammate communicates effectively, is process and data-driven, works well under pressure, eager to learn, will demonstrate effective application of corrective action methodologies, and proven ability to drive permanent corrective actions.

The Quality Manager will be also responsible for leading quality escalations on the production floors and supporting the production team! You will become intimately familiar with our production workflow, and be leading the quality strategy and implementation in the production floor. You will have the support and mentorship of experienced engineers but are expected to work independently. This position will report to the Director of Business Operations.

Essential Duties and Responsibilities

  • Develop quality control processes that meet customer expectations
  • Review and evaluate quality data to identify process improvement opportunities- ability to collect and analyze data to predict trends that will affect the improvement of product quality
  • Define best quality solutions and standards (processes, machines, tools) are being deployed within Manufacturing line
  • Set and monitor supplier quality requirements for raw materials and/or finished goods
  • Lead CAPA’s root cause analysis and track progress of corrective action tasks
  • Drive for quality improvements to constantly improve process and productivity metrics
  • Ensure all processes comply with safety and quality standards
  • Ensure all procedures are updated and controlled as process improvements/changes are released to production
  • Identifying risk and systemic performance issues ensuring root-cause analysis and corrective solutions are identified and implemented with closure plans
  • Driving continuous product and process improvements using statistical and analytical improvement tools such as Six Sigma and lean methodologies
  • Developing and presenting monthly Program Reviews to track Quality Objectives, report to upper management
  • Carry out supplier quality and validation audits, working closely with Supply Chain function
  • Work with Engineering (Design and Manufacturing Engineers) team to define process parameters and criteria to ensure process capability is effective to meet product and process requirements
  • Work closely with Manufacturing team, define and implement Gage R&R program

Education and Experience

  • Bachelor’s degree in Engineering or Engineering Technology
  • 4+ years of experience in quality assurance or manufacturing preferred
  • 2+ years of leadership experience

Required Qualification & Skills

  • Knowledge and experience with the FDA/regulatory documentation
  • Knowledge with QMS (Quality Management Systems)
  • Excel with deploying best Quality tools & practices (6 sigma, Fishbone, RCA, etc)
  • Experience with Statistical Processing tools such as Minitab
  • Ability to tackle multiple projects simultaneously in a dynamic environment.
  • Analytical master - able to produce detailed, data-driven reports using analysis and statistical methods
  • Proven record of building and maintaining QMS tools and systems
  • Must be a self-starter, diligent with deadlines and able to manage oneself in multiple projects
  • Knowledge of manufacturing methods and procedures, manufacturing quality, and process development
  • Strong organizational skills, ability to work with cross functional teams (production, hardware, and software teams)
  • Demonstrates ability of risk-based thinking, effective at failure analysis, design of experiments, and root cause analysis
  • Excellent organizational skills, comfortable working in a fast-paced environment
  • Excellent verbal and written communication/documentation skills

Preferred Qualification & Skills

  • Experience with medical devices
    • Six Sigma Green Belt Certification is a plus
    • Experience with ISO 13845 or medical device regulation is a plus
    • Experience working in a startup environment is a plus
    • Experience with QuickSight, Jira, and/or GitHub is a plus
    • Experience in error proofing techniques such FMEA (Failure Mode and Effects Analysis) is a plus
    • Experience in design validation and control documentation as well as process development and validation studies is a plus

    Physical Demands

    While performing the duties of this job, the individual is regularly required to sit or stand, use hands, reach with hands and arms, see, listen, and speak.

    Perks

    • Unlimited PTO
    • Generous premium coverage for medical, dental, and vision plans
    • Retirement account
    • Paid parental leave
    • Fitness & Wellness Reimbursement
    • Office perks such as food/coffee and flexible work schedules

    We are committed to building a diverse and inclusive company and we are most interested in finding the BEST candidate for the job. We would strongly encourage you to apply, even if you don't believe you meet every one of the preferred qualifications described.

    LightForce has a Mandatory COVID-19 Vaccination Policy, which requires team members to be fully vaccinated against COVID-19 or be approved for a medical or religious exemption with accommodations in order to partake in certain activities in the United States.

    LightForce is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state, or local law.