- FDA regulations
- ASQC Certification
- Communication skills
- Design controls
- ISO 13485
- Employee stock purchase plan
- Health insurance
- Tuition reimbursement
- 401(k) matching
About Natus Medical Incorporated:
Natus Medical Incorporated 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.
We have an exciting opportunity for a Senior Quality Assurance Engineer to join our San Diego team! In this role, you will support the product development process and design transfer to manufacturing and ongoing support of launched products. You will have ownership to develop risk management documentation to address product design and process changes, as well as ensure product and process quality and compliance. You will review and approve change packages, as well as conduct design verification and process validation activities to support daily quality activities in the implementation, maintenance and support of our products that impact patients worldwide.
In this job, you will:
Work with Product Development team to ensure all aspects of Design Transfer activities are being met and comply with the requirements of the quality management system and external regulating agencies
Create, review and approve validations for new and existing products, processes and equipment ensuring systems, utilities and processes comply with regulations and standards
Create validations, adoptions for all types of Sterilization methods (i.e. Eto, Gamma etc.) for implantable medical devices.
Review proposed changes by performing risk assessments, providing guidance, support, and assessing the adequacy of verification and validations and DHF documents
Participate in and author sampling plan development and data analysis for design verification, new/existing product test methods and incoming inspection; ensure predetermined requirements are met
Assist with quality planning activities to ensure design control and risk management compliance according to regulations
Audit internal groups, programs and external vendors for compliance with corporate and international regulatory guidelines
Stay up-to-date and follow all Quality System procedures related to this job, which can affect the quality of products or services provided to our customers
Bachelor's degree (B.A.) from four-year college or university; or equivalent combination of education and experience
5+ years’ experience in a Quality Engineering capacity in the medical device industry
Experience with invasive medical devices, ideally catheters
Hands On experience with sterilization
Experience with design control
Effective communication skills
Knowledge of the FDA Quality system Regulation, ISO 13485, and the Medical Device Directive
Certified Auditor, ASQC desired but not required
Natus offers competitive salaries, comprehensive benefit package that starts on your 1st day, 401k match, 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.