Quality Assurance Specialist
Posted on 3/21/2023
Cambridge, MA, USA
- 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
- Customer service mindset
- Previous hands on experience with design control activities and documentation
Advanced 3D printing systems
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.