HQ - Burlington, MA
At LightForce Orthodontics we use advanced manufacturing technologies and proprietary software to create the world’s best orthodontic treatment experience. We create 100% patient-matched orthodontic ceramic brackets designed from digital impressions with the goal of reducing treatment duration for patients and chair-time for clinicians.
We are looking for a Quality Engineer to join our Physical Manufacturing Team at LightForce Orthodontics. We are seeking a talented and enthusiastic engineer to work on a multitude of quality projects, from analytical quality analysis to quality performance testing, suppliers quality validation and verification of products and processes. Our ideal teammate communicates effectively, is process and data-driven, works well under pressure, and is eager to learn.
The Quality Engineer will be responsible for supporting the production team. This may include projects related to traceability, scaling, quality control, and root cause analysis to name a few! 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.
Essential Duties and Responsibilities
- Address CAPA’s via root cause analysis and design of experiments
- Drive for quality improvements to constantly improve process and productivity metrics
- Ensure all processes comply with safety and quality standards
- Ensure GMPs and SOPs are updated as process improvements/changes are released to production
- Ensure that the best solutions (processes, machines, tools) are being employed within our production line
- Perform process workflow simulations, risk assessments, and process change validation documentation
- Continual evaluation of equipment and processes to ensure high efficiency and quality
- 2-5 years of Engineering Experience
- Bachelor’s degree in Engineering or Engineering Technology
- Knowledge and experience with the FDA/regulatory documentation
- Knowledge with QMS (Quality Management Systems) and best Quality control practices
- Familiar with Quality tools & methods (6 sigma, Fishbone, etc)
- Experience with ISO 13845 or medical device regulation is a plus
- Experience in project management methodologies is a plus
- Experience working in a startup environment is a plus
- Experience with additive manufacturing is a plus
- Ability to tackle multiple projects simultaneously in a dynamic team environment is essential.
- 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
- Experience with medical devices and quality systems
- Experience in design validation and control documentation as well as process development and validation studies
- Self-motivated, data-driven, eager to learn, excellent organizational skills, comfortable working in a fast-paced environment
- Analytical thinker
- Strong verbal and written communication/documentation skills
- Experience with QuickSight, Jira, and/or GitHub is a plus
- Flexible vacation
- Generous premium coverage for medical, dental, and vision plans
- Retirement benefits / accounts
- Pre-tax commuter benefits program
- Paid parental leave
- Workplace perks such as snacks/coffee and flexible work schedules
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
LightForce Orthodontics 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.