US, US, CA - San Diego
Minimum Level of Education Required: Bachelors Degree
Percentage of Travel: Up to 10%
Location: CA - San Diego
Develop Quality Plans for the product development team.
Lead the development of adequate inspection criteria. Identify the need for custom gaging for NuVasive and suppliers.
Identify and qualify equipment required to perform inspection.
Support transfer of design to contract manufacturer, including establishment of inspection plans both at NuVasive and at the supplier.
Evaluate product changes for qualification and validation requirements and assist in change implementations.
Establish and implement systems to ensure timely quality inspections for incoming materials, components or finished goods products. Work with engineering to develop adequate inspection criteria. Perform inspections as needed, or ensure that inspections are performed by qualified personnel, and that inspection results and documentation support the recommended disposition action.
Support Design Control activities such as Risk Assessment, supplier quality plans, design verification and design validation and sterilization/packaging validation.
Qualify and manage subcontract supply base, including on site audits, quality agreements, corrective actions and validations.
Develop new quality initiatives, participate in quality system development, procedure writing and review, and improve quality and reliability of products
Support Non-Conforming Material Program.
Conduct investigations, initiate or process actions from quality system feedback information (records review, acceptance activities, non-conforming materials reports, corrective action reports, complaints, and audit reports) as needed.
Support the analysis and presentation of information to executive management concerning measures of product and service quality, supplier performance, manufacturing problems, and design issues as identified through various quality systems program elements.
Other functions include:
Review technical publications, articles, and abstracts to develop applicable skills and to stay abreast of quality, regulatory, compliance, and technical developments in the industry.
Attend such conferences, seminars, professional meetings, and other public forums as are relevant to the interests of NuVasive.
Support other work of the Q.E. Department, as required.