Quality Assurance Specialist
Posted on 3/21/2023
Cambridge, MA, USA
Experience Level
Desired Skills
Customer Service
  • Serve as quality SME for new product development and design changes, by ensuring quality standards are met during all phases of the product life cycle
  • Work closely with cross-functional teams including R&D and manufacturing to assure that the requirements of the quality management system are being met
  • Writes, reviews and approves design control documents for new product development and design changes in accordance with the quality management system
  • Performs monitoring, review, and audit activities of quality management records/documentation and quality management system processes to assure regulatory and system compliance
  • Supports development of Department Operating Procedures and Standard Operating Procedures
  • Coordinate and support execution of supplier qualification activities
  • Supports laboratory equipment management and upkeep including managing equipment calibration
  • Assist in maintaining, updating, revising, and storing documentation per company procedures
  • Support change management documentation, review and approval
  • Support the development of corrective action plans for materials and investigate non-conformances utilizing established quality engineering techniques
  • Bachelor's Degree (B.S.) in Chemical Engineering, Life Sciences, or a related field
  • 3 years of experience in regulated industry
  • Knowledge of regulatory compliance requirements, design controls, and risk management, including 21 CFR 820, ISO 13485, and ISO 14971
  • Prior hands on experience with basic lab/instrumentation
Desired Qualifications
  • Customer service mindset
  • Previous hands on experience with design control activities and documentation

501-1,000 employees

Advanced 3D printing systems
Company Overview
Formlabs is reinventing 3D printing by expanding access to digital fabrication, so anyone can make anything.
  • Flexible vacation
  • Premium coverage for medical, dental, and vision plans
  • Paid parental leave
  • Commuter benefits
  • Unlimited 3D prints
Company Core Values
  • Autonomy: We leave space for people to do their best, and take initiative to chart their own career course.
  • Cutting Edge: We’re building things that haven’t been built before, so we can push the edge of what’s possible.
  • Results: We dream big, but our focus on getting things done is what drives us forward.
  • Curiosity: We are always asking why to push ideas and actions beyond the status quo.