Document Control Specialist
Location: Somerville, MA
When breaking new ground in an industry, you have to build the best team. Join Formlabs if you want to bring groundbreaking professional 3D printers to every designer, engineer, researcher, and artist in the world.
Our growing Quality team ensures the Formlabs products are consistent and reliable. We're the team that interprets incoming data and implements changes in manufacturing, software, materials, and hardware design.
Do you want to use your documentation skills to improve internal processes and fix product issues? We want you to join our team as a Document Control Specialist.
- Design and maintain our engineering documentation strategy, including best practices and file structure
- Maintain PLM systems for accuracy and accessibility
- Maintain controlled documents, compliant with organizational policies, Good Manufacturing Practices (GMPs), and Good Laboratory Practices (GLPs).
- Collaborate with the Design Engineering and Manufacturing Engineering teams to process engineering change orders
- Ensure that process changes at our suppliers are recorded, planned, authorized, communicated, and implemented in accordance to company standards.
- Coordinate product and process changes with all relevant departments (Quality, Engineering, Manufacturing, Materials, Purchasing, Operations).
- Bachelor’s degree preferred
- 3+ years of recent, applicable GMP experience in the medical device/product development industry building or directly supporting a Change Control System, ideally in both an ISO and FDA/CDRH regulated quality system
- Experience authoring, editing, and managing change control on technical documentation
- Working knowledge of documentation functions of a medical device or product development company preferred
- Working knowledge of engineering, design, and manufacturing concepts
- Experience with a Product Lifecycle Management (PLM) tool, e.g. Oracle, Arena, Omnify, or Propel
- Experience working in a regulated environment with GDP (good documentation practices)
- Flexible Vacation
- Premium coverage for medical, dental, and vision plans
- Paid parental leave
- Commuter benefits
- Unlimited 3D prints
We're an equal opportunity employer and value diversity in our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Even if you don't check every box, but see yourself contributing, please apply. Help us build an inclusive community that will change the face of 3D printing.