Quality Assurance Specialist Jobs

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!

The Job:

• Support the development of corrective action plans for materials and investigate non-conformances utilizing established quality engineering techniques
• Assist in maintaining, updating, revising, and storing documentation per company procedures
• Performs monitoring, review, and audit activities of quality management records/documentation and quality management system processes to assure regulatory and system compliance.
• Supports laboratory equipment management and upkeep including managing equipment calibration
• 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
• Writes, reviews and approves design control documents for new product development and design changes in accordance with the quality management system.
• Supports development of Department Operating Procedures and Standard Operating Procedures.
• Support change management documentation, review and approval.
• Coordinate and support execution of supplier qualification activities
• Work closely with cross-functional teams including R&D and manufacturing to assure that the requirements of the quality management system are being met.

You:

• 3 years of experience in regulated industry
• Prior hands on experience with basic lab/instrumentation
• Bachelor's Degree (B.S.) in Chemical Engineering, Life Sciences, or a related field
• Knowledge of regulatory compliance requirements, design controls, and risk management, including 21 CFR 820, ISO 13485, and ISO 14971

Bonus:

• Previous hands on experience with design control activities and documentation
• Customer service mindset

Our Perks:

• Ample on-site parking & pre-tax commuter benefits
• Tenure-based paid Sabbatical Leave (up to 6 weeks)
• Robust equity program to build future wealth through RSUs
• Flexible Out of Office Plan – Take time when you need it
• Many opt-in culture events across our diverse community
• Healthy on-site lunches, snacks, beverages, & treats
• And of course… unlimited 3D prints!
• Generous paid Parental Leave (up to 16 weeks)
• Comprehensive healthcare coverage (Medical, Dental, Vision)
• Low cost fund options in our 401K and access to advisors
• Regular sponsored professional development opportunities

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.