Natus Medical is a leading manufacturer of medical devices for the Newborn Care, Neurology, Sleep, Hearing and Balance markets since 1989. Natus products are used in hospitals, clinics and laboratories worldwide. Our mission is to improve outcomes and patient care in target markets through innovative screening, diagnostic and treatment solutions.

Job Summary:

As a successful Quality Engineer - Contract (Onsite Work Schedule at San Diego - 5955 Pacific Center Blvd, San Diego, CA 92121), you will provide Quality compliance support for the following Quality tasks and duties. Support the transfer of products and processes to a new manufacturing site Review installation, operation and performance validation protocols and reports to ensure compliance to Natus procedures and policies. FDA and ISO 13485 (and other applicable standards) requirements.

In this job, you will:

• Reviews protocols and reports to ensure compliance to Natus procedures and policies, FDA and ISO 13485 requirements.
• Assist manufacturing engineers to establish statistically based sampling plans for validation and verification protocols.
• Develops, reviews, and approves validations and completion reports for existing products, processes and equipment. Provides statistical analysis of the data to support the reports.
• Ensures that all projects follow GLP, QSR (including Design Controls), ISO or other applicable requirements.
• Formulates detailed product quality plans based on results of risk analysis.
• Supports the Quality Management Review Process as required.
• Identifies opportunities for continuous improvement.
• Interacts and coordinates activities with other departments.
• Works with manufacturing engineering transfer team to ensure all aspects of product and process transfer activities are being met.
• Assists or leads in the prompt implementation of Non-Conformance resolution, and Corrective & Preventative Action(s) (CAPA support) as required.
• Performs other Quality Systems related duties as required.

Qualifications:

• Bachelor's degree from college or university in an engineering or scientific discipline with minimum 4 years related Quality Assurance Engineering experience in the medical device industry. Equivalent combination of education and experience may be considered.
• Possess a good working knowledge of regulatory expectations and industry practices including industry standards QSR, ISO13485, MDD, MDR, CMDR, JPAL
• Excellent organizational; problem solving; decision-making; communication (oral and written); and influencing skills

Pay Rate: $45 to $60 / hour based on experience level

EEO Statement:

Natus Medical is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status.