Quality Assurance Specialist
Location: Somerville, MA
To reinvent an industry, you have to build the best team. Join Formlabs if you want to bring ground-breaking professional 3D printers to the desktop of every designer, engineer, researcher, and artist in the world.
This position offers autonomy and ownership of QA for our Materials Science team. If you have experience in a regulated industry and are ready to support the growth of additive manufacturing in the medical device field, join us as a Quality Assurance Specialist!
- 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
- Flexible vacation
- Premium healthcare coverage
- Paid parental leave
- Commuter benefits
- Unlimited 3D prints
We are an equal opportunity employer and value diversity at 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.
To all recruitment agencies: Formlabs does not accept agency resumes. Please do not forward resumes to our jobs alias, Formlabs employees or any other company location. Formlabs is not responsible for any fees related to unsolicited resumes. Unsolicited resumes received will be considered our property and will be processed accordingly.