Sr. Quality Engineer
Orange County Metro Area, California
Critical review and approval of design changes; partner with R&D in the design of safe and reliable THV devices.
Partner with Manufacturing Engineers to develop critical manufacturing processes and provide technical quality support for the pilot production of clinical devices.
Root cause analysis investigation for component and device non-conformance or failure.
Managing purchased component quality issues and working directly with suppliers or Supplier Development teams.
Provide technical quality support for design qualifications, design transfer, and activities for Regulatory submissions.
Develop and implement risk management documentation including risk management plans and design, application, and process FMEAs.
A Bachelor of Science degree in Mechanical, Biomedical, or equivalent engineering degree is required.
Minimum of 4 years experience in Quality or Manufacturing is required.
Experience in design verification, risk management, and design control in the medical device industry or other regulated industries is required.
Must be able to work effectively and collaborate within cross functional teams.
Must be able to effectively articulate (verbally and in writing) results and conclusions to technical and non-technical personnel.
Must have strong documentation skills.
Must take initiative and have the ability to work hands-on with product and equipment.
Must possess the ability to handle multiple tasks with high attention to detail.