Quality Engineer, New Product Development (NPD), West Irvine, CA

Providing Quality System Regulatory interpretation, consulting, training, and assessment of the organization to ensure product teams are aligned with current regulatory requirements, standards, and current industry trends.
Making technical decision on product fitness for reliability and guides the product team towards their goal and drives reliability implementation for products and demonstrates leadership abilities to drive reliability implementation for products
Ensuring that documented evidence exists to provide a high degree of assurance that specific design and processes will consistently and continually produce a product, meeting its current specifications and quality attributes.
Leading project teams to utilize risk management and process excellence tools and effectively drives reasonable and appropriate risk controls.
Leading, supporting and conducting product design verification, and product and process validation activities.
Conducting or support failure and complaint investigations.
Initiating and supporting continuous process improvements within area of responsibility, and conducting supplier quality system and product audits.

Qualifications:
A minimum B.S. in Electrical or Biomedical Engineering or equivalent with 5 - 7 years of related experience.
Strong quality engineering skills with working knowledge of: product design verification, and product and process validation activities.
Ability to provide an expert knowledge of both regulatory requirements and other compliance areas to minimize risk across franchise
Expert knowledge of both risk analysis and identification of effective risk controls. Ability to assess products, projects and activities using process excellence tools to determine risk-benefit balance with regard to clinical/patient, business/commercial, regulatory and technical risks.
Ability to utilize knowledge of Human Factors and Design during the design and evaluation of products
Ability to use problem solving techniques including root cause analysis and cause and effect analysis, Statistical techniques and methods.
Ability to integrate Reliability techniques as a part of Product Development or Design Changes.
Ability to develops the Reliability Requirement for products in partnership with R&D, operation, Marketing, Sales, Sourcing teams.
Ability to demonstrate leadership abilities to drive reliability implementation for products.
Working knowledge of Microsoft office products (Word, Excel, Access, and Project).
The qualified candidate for this hands-on position should be able to use Quality Engineering principles, tools, and practices to develop and optimize systems and processes that are aligned with the overall business and quality vision. The individual must be capable of working independently and in a team setting supporting the new Product Development or Design Changes.