What are the responsibilities and job description for the Senior Quality Engineer position at Skills Alliance?
🤖 Senior Quality Engineer I | Surgical Robotics
📍 Milwaukee, Wisconsin (On-site) | Competitive Salary
This is a hands-on quality engineering hire for a market-leading medical technology company, supporting contract manufacturing of surgical robotic systems. You will own installation, calibration, validation and final quality control of robotic cart and tracker stand systems, working at a contract manufacturer site and ensuring every unit meets spec, regulatory requirements and release criteria before it ships.
Working closely with Manufacturing, R&D, Software and Supplier Quality teams, you will take these robotic systems through system integration verification and validation, resolve issues as they arise and drive products to a state of readiness for the field.
What you will own:
- Leading onsite quality engineering activities for robotic cart and tracker stand systems at a contract manufacturer facility
- Overseeing and executing clinical software installation and configuration on robotic carts and display systems
- Performing and validating robotic arm and camera (infrared tracker) calibrations
- Ensuring completion of system integration verification and validation activities
- Executing and approving final QC testing, including electrical safety, functional, software and hardware integration testing
- Collaborating cross-functionally to resolve issues and drive product readiness
- Authoring and maintaining quality documentation, test procedures, calibration records and device history records (DHRs)
- Supporting nonconformance investigations, root cause analysis and CAPA activities
- Providing technical guidance and training to manufacturing personnel
- Participating in internal and external audits (FDA, notified bodies, suppliers)
What you must have:
- Bachelor's degree in Engineering (Mechanical, Electrical or Biomedical preferred) with 3 years of relevant experience
- Hands-on experience with robotic systems, electromechanical assemblies or imaging systems
- Experience with system integration, calibration processes and software-hardware interfaces
- Strong knowledge of medical device regulations (FDA QSR, ISO 13485)
- Knowledge of validation (IQ/OQ/PQ), calibration methods and quality tools (FMEA, CAPA, DMAIC)
- Experience working with contract manufacturers and supplier environments preferred