Support the maintenance of quality system requirements, including: CAPA system, external, internal and supplier audits, quality metrics reporting, management review preparation, and training
In this job, you will:
Establish and update quality system procedures in compliance with requirements for medical devices
Be process owner (SME) for corrective and preventive action system (CAPA)
Plan and conduct quality system audits in accordance with documented procedures
Provide oversight and support for the Supplier Quality Management activities by conducting Operations and Quality audits for subcontract manufacturers and critical component suppliers
Lead Quality and Regulatory efforts with production site transfer and outsourcing efforts
Support/manage external audits and regulatory inspections
Prepare metrics in support of trending and management review
Support Quality Assurance, Quality Control, and Regulatory functions as necessary
Bachelor's degree (B.S.) from a four-year college or university in the sciences or related field; or related experience
Have a minimum of 5-7 years of experience in Quality within a medical device company (electronic medical device experience a plus)
Have experience working with the following regulations: The Food and Drug Administration’s Quality System Regulations (FDA QSRs), International standards such as ISO 13485, ISO 14971, Medical Devices Directive (MDD), and Canadian Medical Device Regulations (CMDR).
Have experience working on product development teams following Design Controls and Risk Management processes
Experience with statistical analysis of quality data
Software validation experience a plus
Direct experience managing or participating in an FDA and other agency audits a plus
Founded in 1989, Natus Medical Incorporated is a leading manufacturer of medical devices and software and a service provider for the Newborn Care, Neurology, Sleep, Hearing and Balance markets. 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 solutio...ns.
Products manufactured by Natus are sold through a combination of a direct sales force and worldwide distribution partners. Natus products are sold and supported in over 100 countries. Among the many benefits provided to our customers is the NERVE Center, Natus’ education portal supporting our customers with ongoing product and clinical training and education.