Sr. Quality Engineer

Quality Engineer is responsible for improving quality and reliability of products and leading failure investigations of alleged product field failures. This position will interface with manufacturing, engineering, suppliers and internal/external customers.
+ To actively lead product complaint investigations applying a Process Excellence approach using quality tools such as FMEAs, Hazard Analysis, Process Flow Maps, and DOEs.
+ Responsible for test protocol development, root cause analysis, and report writing. Assist in the development and implementation of appropriate corrective action plans.
+ To ensure that conclusions from investigations are appropriately supported by facts, that corrective and preventive actions address the root cause, and all aspects of the investigations are thoroughly documented.
+ To recommend changes to products or specifications, as required, improving quality performance.
+ To establish and track appropriate measures of quality for field complaints and defects and communicating these to management. Ensure that indicators with poor outcomes are addressed through an appropriate action plan.
+ To lead decisions and execution of Ship Holds and Recall activities.
+ To lead efforts to complete Health Hazard Evaluations (HHEs) to ensure timeliness, accuracy of the information, and complete documentation.
+ To participate in New Product Introductions as required in the Development process and ensure appropriate design transfer into Manufacturing.
+ To identify and lead opportunities to continuously improve, using appropriate Process Excellence and Lean Manufacturing tools, quality, cost and time factors consistent with Cardiac Science business objectives.
+ To ensure that assigned CAPA records are progressing within timelines. Provide guidance, as appropriate, to CAPA owners and ensure that conclusions from CAPA investigations are supported by facts and all aspects of the CAPA are thoroughly documented.
+ Interface with Supplier Quality Engineers to drive improvements relating to component quality.
+ May participate in the MRB.
+ Supervises defective material sorting on the manufacturing line when necessary.
+ Comply with company policies and procedures regarding Employee health, safety, and conduct.
+ B.S. Degree in Science or Engineer or equivalent experience
+ 5+ years of experience in an FDA regulated medical device company or IVD Manufacturing company.
+ A thorough understanding of US FDA QSRs and ISO 13485
+ Thorough understanding of quality improvement tools such as Six Sigma and Lean Manufacturing.
+ Strong knowledge of statistical methods, including statistical process control and sampling techniques.
+ Demonstrated failure analysis experience working across functional groups to determine root cause.
+ Must be a self starter and able to manage a variety of tasks simultaneously with minimal day-to-day supervision.
+ Excellent analytical and written and oral communication skills and the ability to work well under pressure with cross ? functional Teams.
+ Computer literate in Word, Excel, Minitab, and PowerPoint.
Desired Qualifications:
+ Experience with FDA Class III medical devices.
+ Experience with complex electrical systems, medical control systems, or embedded software
+ Strong knowledge of applicable IPC standards for printed circuit boards
+ ASQ, or equivalent, Quality Engineering certification.
+ ISO 13485 Lead Auditor Certification.
+ Six Sigma Certification.
Cardiac Science is an Equal Opportunity Employer - Minorities/Females/Veterans/Disabled
ID: 2817 20a0ec8296b34f578c618b6207a6de66

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