Senior Quality Engineer

Horizon Surgical Systems; Los Angeles (CA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive compensation

Excellent company-paid benefits

Job summary

Horizon Surgical Systems in Los Angeles is looking for a Senior Quality Engineer to oversee quality assurance throughout product development and manufacturing. The ideal candidate will have at least 5 years of experience in the medical device field, expertise in design control, and effective communication skills.

Join us in pioneering AI-driven innovations to transform surgical ophthalmology with competitive compensation and a comprehensive benefits package.

Qualifications

• 5+ years experience as a Quality Engineer in medical device industry.
• Expertise with design control.
• Strong preference for software and firmware V&V experience.

Responsibilities

• Establish quality requirements at all phases of development and manufacturing.
• Perform product V&V activities including sterilization and packaging.
• Manage supplier activities and maintain the Approved Suppliers List.

Skills

Problem-solving skills

Team orientation

Effective communication

Expertise with design control

Knowledge of regulatory requirements

Education

BS degree in Engineering or life sciences

Advanced degree preferred

Job description

Open Position – Senior Quality Engineer

Horizon Surgical Systems Inc. is revolutionizing the world of surgical ophthalmology by developing a novel, AI-driven, imaging-guided surgical robotic system. Our mission is to expand access to care, provide superior capabilities to the surgeon, and enhance patient outcomes. Microsurgery and ophthalmology are subfields in which robotic systems can significantly improve surgical outcomes by providing superior dexterity, precision, accuracy, and visualization beyond human capabilities.

Core Values

• Commitment to Excellence: Deliver superior patient outcomes and surgeon experiences.
• Passion for Creativity and Innovation: Drive new ideas and push the boundaries of what is possible.
• Teamwork and Camaraderie: Achieve our best through collaboration and teamwork.
• Welcoming of Critical Opinion: Enrich our work with constructive criticism and support the best ideas.
• Personal Accountability: Honor commitments and take responsibility for our actions.

What We Offer

• An opportunity to build autonomous surgical robotic systems driven by image guidance and AI technology for affordable, high-quality healthcare.
• Collaborate with clinicians, engineers, and global leaders in cutting-edge AI, imaging, and robotics technology.
• Competitive compensation and an excellent company-paid benefits package.

Responsibilities & Duties

• Work with Product Development and Operations teams to establish quality requirements at all phases of product/process development and manufacturing.
• Perform product V&V activities including sterilization, packaging/labeling, transit testing, real-time/accelerated aging, and create protocols and reports.
• Support the Risk Management Process and maintain the Risk Management File.
• Maintain the Design History File, device Master Record, and related documentation.
• Set up the receiving inspection area and conduct materials inspection such as incoming inspection, First Article Inspection, and final product release.
• Document product discrepancies and follow up on nonconformance implementation and closure.
• Manage supplier activities including sourcing, qualifying suppliers, maintaining the Approved Suppliers List (ASL), and overseeing the Supplier Corrective Action Request (SCAR) program.
• Manage CAPA from generation through implementation, verification of effectiveness, and closure.
• Assist with internal audits and host external audits, driving issues to closure.
• Ensure product packaging/labeling conforms to applicable regulations.
• Perform other duties as assigned.

Required Qualifications

• BS degree in Engineering, life sciences, or related field; advanced degree preferred.
• 5+ years experience as a Quality Engineer or in a related field in the medical device industry; ASQ CQE a plus.
• Expertise with design control.
• Strong preference for experience with software and firmware V&V.
• Knowledge of regulatory requirements such as QSR, MDR, ISO and ability to generate procedures in compliance.
• Excellent people skills and team orientation.
• Strong problem-solving skills.
• Effective written and verbal communication and organizational skills.
• Ability to coach others or teach the proper use of quality tools and problem-solving techniques.

This is an exciting opportunity to join a high-tech startup poised to revolutionize surgical robotics in ophthalmology.