Quality Engineer

Capstan Medical · Santa Cruz, California, United States · onsite

Skills:

- Strong understanding of quality management systems.

- Excellent problem-solving skills and ability to apply root cause analysis methodologies.

- Detail-oriented with effective organizational and documentation skills.

- Strong communication and collaboration skills to work cross-functionally and interact with technicians, engineers, auditors, and third parties.

- Attention to detail, with a focus on accuracy and precision in quality-related activities.

- Ability to work independently in a fast-paced organization with competing priorities.

Requirements:

- Bachelor's degree in Engineering or a related technical field. Master's degree is a plus.

- Knowledge of FDA regulations, ISO 13485, and other relevant quality standards for medical devices.

- Experience working in a cleanroom manufacturing environment.

- Experience with nonconforming material investigations and implementing effective CAPAs.