Job Description
Job DescriptionAt Capstan Medical, we’re driven by an unwavering commitment to transforming the treatment of heart valve disease. By merging surgical robotics with catheter-based technology and next generation implants, we’ve pioneered a patient-optimized approach to repair and replace heart valves.
Our innovative technology offers a significantly less invasive alternative to traditional open-heart surgery while ensuring precise and reliable placement of the heart valve implant. With these advancements, we may be able to provide patients with a solution to their heart valve disease while significantly reducing recovery time and minimizing the risk of complications. With a dedicated team of heart valve device experts and robotics engineers, we are fully committed to developing a comprehensive and transformative solution that will positively impact the lives of individuals affected by this condition.
Capstan Medical is uniquely positioned in Santa Cruz. This gives us access to the amazing technical talent of the Bay Area, but in an environment that we feel is conducive to doing our best creative work. Our office is adjacent to large tracts of open space with bicycle trails straight from the office doors offering access to the hills and beaches of Wilder Ranch State Park for road/mountain bicycle riding, hiking, and surfing.
Come join us and become part of a team revolutionizing heart valve treatment!Description:
- Perform in-line and final inspections of delivery catheters in accordance with approved procedures and specifications
- Conduct product label and packaging inspections to verify accuracy and compliance with approved procedures and requirements
- Inspect returned devices and document findings in accordance with established processes
- Review quality records such as Device History Records (DHRs) for completeness, accuracy, and compliance
- Identify and document nonconforming materials or processes; initiate Nonconformance Reports (NCRs) as required
- Support investigation and resolution of quality issues in collaboration with Manufacturing and Engineering teams
- Represent Quality Assurance on the manufacturing floor and provide real-time quality guidance
- Maintain accurate inspection records and ensure timely data entry into quality systems
- Adhere to cleanroom protocols, safety procedures, and Good Manufacturing Practices (GMP)
Skills:
- Familiarity with inspection tools and techniques, including visual and dimensional inspection
- Working knowledge of quality systems, documentation practices, and GMP requirements
- Strong attention to detail and ability to follow written procedures
- Effective communication and teamwork skills
- Basic computer proficiency, including experience with electronic quality systems and Microsoft Office
Requirements:
- Excellent verbal and written communication skills.
- AA degree or equivalent directly transferrable work experience
- Minimum of 3 years of professional experience working in quality inspection or manufacturing within the medical device industry
Why join us:We offer a fun, fast-paced, collaborative environment where you will be working on transformational technologies in the cardiac healthcare space.We offer outstanding benefits with medical, dental, and vision covered at 100% for you and your family, as well as flex time off. We thrive in our work-hard, play-hard environment. Bring your bike or running shoes if you’d like or just be ready to enjoy a fun office outing. We enjoy time inside the office and out!
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, veteran status, and disability, or other legally protected status.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.