Description:
We are seeking a highly skilled and motivated Quality Control Technician to join our team. The Quality Control Technician is responsible for incoming inspection of purchased materials, reviewing and storing quality records, and providing general support to the quality function.
The IQC responsibilities include:
- Perform thorough visual and dimensional inspections of incoming materials, components, and their paperwork to verify conformance to specifications and quality standards.
- Create and maintain quality records for components and materials used in the production of medical devices.
- Utilize appropriate measuring instruments and equipment to conduct inspections effectively.
- Perform component inspections using Keyence measurement and/or visual system.
- Record and analyze inspection data, ensuring compliance with acceptance criteria and quality standards.
- Follow sampling plans and inspection procedures to ensure consistency and accuracy in inspections.
- Identify and document any non-conformities or deviations from specifications, segregate product, and escalate issues to the appropriate stakeholders.
- Maintain accurate and organized records.
- Observe and enforce good documentation practices.
- Perform Controlled Environment Room monitoring and maintain associated quality records.
Other quality responsibilities include:
- Review quality documents (Device History Records, Nonconforming Reports, Calibration reports, Manufacturing records, etc) for completeness and compliance to procedures.
- File and maintain quality records.
Skills:
- Demonstrated knowledge of Metrology and Inspection Technique.
- Ability to use hand tools, calibrated instruments, measurement equipment, microscopes, and testing fixtures.
- Attention to detail.
- Ability to work independently.
- Proficiency with written and spoken English.
- Strong communication skills.
- Ability to use Microsoft Office applications.
Requirements:
- Minimum of 3 years of experience in a quality control role, experience in the medical device industry preferred.
- Experience working in a cleanroom manufacturing environment.
- High school diploma or equivalent.
- Basic understanding of Quality System Regulation.
- Ability to prioritize and organize work independently.
- Flexible and comfortable in a fast-paced work environment.
- No medical conditions preventing access to a Controlled Environment Room.
Overview
Capstan Medical: Creating a new standard for minimally invasive structural heart treatment
At 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 a precise and reliable placement of the heart valve implant. With these advancements, we may be able to provide patients 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.