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About the Role
Andromeda is seeking a Quality Engineer to enhance the production of autonomous surgical robots. This role involves developing and implementing quality processes for equipment, calibration, supplier management, and verification, with a focus on automation and efficiency. The position offers significant ownership and the opportunity to shape the quality system in a growing company.
Responsibilities
- Support daily builds by ensuring parts, equipment, and records are ready and correct.
- Address quality issues during the build process.
- Manage supplier and incoming quality, including supplier qualification and inspection criteria.
- Oversee the equipment and calibration program, including scheduling, records, and vendor management.
- Write and execute verification protocols and specify associated fixtures.
- Support design control and changes, including managing inputs, outputs, traceability, and verification requirements.
- Automate manual processes to improve build speed and reduce errors.
- Identify and simplify manual checks, records, and handoffs.
- Contribute to the evolution of the quality system and its future direction.
Requirements
- 2 to 3 years of quality or regulatory experience in medical devices or a similarly regulated industry.
- Working knowledge of ISO 13485 and 21 CFR Part 820 / QMSR.
- Understanding of how quality regulations apply to design control, supplier control, and equipment.
- Proficiency in inspection, metrology, and calibration, including reading engineering drawings and managing equipment status.
- Experience with design control and V&V methods, including protocol and report writing, acceptance criteria, sample-size rationale, and traceability.
- Ability to define and manage programs simultaneously.
- Comfort working with incomplete information and shifting priorities.
- Proactive in identifying and simplifying manual processes.
- Strong written communication skills for documenting evidence.
- Ability to collaborate effectively with engineering and technical teams.
Skills
- Quality Engineering
- Regulatory Affairs
- Medical Device Quality Systems
- ISO 13485
- 21 CFR Part 820 / QMSR
- Design Control
- Supplier Quality Management
- Incoming Inspection
- Equipment Calibration
- Metrology
- Verification and Validation (V&V)
- Process Automation
- Mechanical Inspection
- GD&T
- Machining Processes
- Software Verification
- Software Validation
- Statistical Methods
- Sampling Plans (AQL, C=0)
- Reliability Testing
- Auditing (Internal, Supplier)
- Surgical Robotics
- Electromechanical Devices
Location
- Remote
Work Type
- Full-time
Experience Level
- Mid-level
Education Level
- ASQ CQE (preferred)
About the Company
- Andromeda is developing autonomous surgical robots to improve surgical safety, consistency, and efficiency.
- The company fosters a collaborative environment valuing ownership, curiosity, technical rigor, and rapid execution.
- Engineers work across robotics, software, hardware, machine learning, and clinical operations.
- The quality system is established and certified to ISO 13485 and MDSAP.