Senior Quality Engineer

Skills Alliance; Milwaukee (WI); On-site; USD 85,000 - 110,000; Full time

Job summary

Skills Alliance seeks a Senior Quality Engineer I for Surgical Robotics to own hands-on quality activities at a contract manufacturer site. You will supervise installation, calibration, validation and final QC of robotic cart and tracker stand systems to ensure each unit meets specs and regulatory release criteria.

You will collaborate with Manufacturing, R&D, Software and Supplier Quality teams to drive system integration verification, issue resolution, and readiness for field deployment.

Qualifications

• Hands-on engineering experience with robotic systems, electromechanical assemblies or imaging systems.
• Knowledge of medical device regulations (FDA QSR, ISO 13485).
• Experience with system integration, calibration processes and software-hardware interfaces.

Responsibilities

• Lead onsite quality engineering activities for robotic cart and tracker stand systems at a contract manufacturer facility.
• Oversee clinical software installation and configuration on robotic carts and display systems.
• Perform and validate robotic arm and camera (infrared tracker) calibrations.
• Ensure 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.

Skills

Robotics systems

System integration

Calibration methods

CAPA

FDA QSR

ISO 13485

DMAIC

DHR documentation

Education

Bachelor's degree in Engineering

Tools

Calibration equipment

Job description

Senior Quality Engineer I | Surgical Robotics

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