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 solutions.
SUMMARY: Support new product development and design change activities for Natus products. Support the maintenance of quality system requirements, including internal and supplier auditing, Corrective and Preventive Action (CAPA), risk management, product and process issues, and provide general support of the quality system. Works on a wide range of quality issues related to Quality Systems, Product Quality, and Supplier Management.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Perform design quality engineering tasks.
Establish and update quality system procedures in compliance with requirements for medical devices
Participate in quality system audits in accordance with documented procedures.
Participate in Supplier Quality Management activities by conducting Quality audits for subcontract manufacturers and critical component suppliers
Support/maintenance of technical files, MDD certification and declarations of conformity in support of EU product registrations/CE mark.
Assists in the investigation and resolution of complaints.
Supports the CAPA system as a CAPA owner or team member.
Supports Quality Assurance, Quality Control, and Regulatory functions as necessary.
Travel Required: minimal to moderate
Education and/or Experience:
Bachelor's degree (B.S.) from a four-year college or university in the sciences or related field, with a minimum of 5 years of experience in Quality Assurance / Engineering in an electro-mechanical medical device company. Current knowledge of FDA and international quality system requirements are a must.
Certificates, Licenses, Registrations:
Certification by ASQ as certified quality auditor (CQA) or quality engineer (CQE) is a preferred.
ISO 13485:2016 Lead Auditor certification is preferred.
Natus offers competitive salaries, comprehensive benefit package that starts on your 1st day, 401k match, an employee stock purchase plan, 9 paid holidays, generous paid time off plan (4 weeks to start) and tuition reimbursement up to $5,000 annually.
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.
Natus Medical Incorporated