Job Details

SUMMARY/RESPONSIBILITIES:

This position will be responsible for product quality control/assurance and day to day operational activities in an FDA regulated environment supporting manufacturing and commercialization of Neurolutions stroke rehabilitation products. You will fill an important role in the company’s success as you work cross-functionally with support from quality and regulatory experts to ensure products and processes meet requirements established in the Quality System.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:

• Manage day to day QA/QC activities including receiving inspection, physically maintaining stock, maintaining equipment lists, review and release production documentation, processing non-conforming material and other processes.
• Manage returned materials/RMA and customer complaints including bench level product failure troubleshooting/diagnosis and complaint analysis.
• Establish and ensure supplier quality with assessments and auditing.
• Analyze product failure rates, returns and patient complaint trends to support periodic management reviews.
• Play a key role in support of internal and external regulatory audits.
• Support engineering and manufacturing product validations, testing and other efforts.
• Update documentation and procedures to support continual improvement of company’s quality system, document management system and product lifecycle management systems.
• Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.

EDUCATION/EXPERIENCE:

• Bachelor’s degree in technical field such as biology, engineering, physics, or mathematics.
• 5+ years as a quality engineer in a Class 2 or 3 medical device environment (or similar), clinical studies, cGMP, and ISO 13485 preferred. Similar related QA/QC experience will be considered.
• Strong knowledge of ISO requirements, GMP guidelines, FDA regulations and medical device design controls.
• Familiarity with mechanical drawings, GDT principles and physical inspection methods.
• Experience with inventory management, document control and PLM systems

OTHER SKILLS REQUIRED:

• Creative, motivated individual with an excellent work ethic and the passion to succeed.
• Excellent analytical, communication and organizational skills and strong attention to detail.
• Ability to work independently on assigned projects with minimal supervision with a strong self-starter work ethic.
• Enthusiasm for working in a small team and developing products that will affect the lives of stroke survivors.

Location: Santa Cruz, CA (fully on-site)