HireDiversity

Milpitas, CA, US

Senior Operations Quality Engineer-6019120926

Description

The Diabetes Care Franchise (DCF), a member of the Johnson & Johnson Family of Companies, is recruiting for a Senior Operations Quality Engineer that will be located in the Milpitas or Redwood City, CA.

The Diabetes Care Franchise (DCF) now includes Calibra Medical Inc. Calibra Medical is the developer of a unique, wearable three-day insulin patch designed to offer a convenient and discrete mealtime insulin dosing option for people with diabetes who take multiple daily injections (MDI) of insulin (www.myfinesse.com). This new insulin patch is intended to make it easier for patients to adhere to their prescribed mealtime insulin therapy and help them achieve and maintain good diabetes control.

The Senior Operations Quality Engineer provides Quality Engineering support for base business, new product development, or supplier quality. Products include molded parts, mechanical components and assemblies.

The incumbent is responsible for utilizing effective and efficient Quality Engineering techniques such as risk analysis, test method development, design of experiments, statistical data analysis, measurement system analysis, and development of sampling plans throughout the product lifecycle. They must develop and execute comprehensive quality strategies for design development, verification and validation. They will also develop and execute Master Validation Plans.

A successful candidate will lead/conduct and participate in troubleshooting investigation efforts utilizing problem solving methodologies. They must identify trends and reoccurring issues and suggesting solutions, develop and validate appropriate test methods to assess product performance, and effectively utilize appropriate methodologies to develop optimal products and processes. They will partner with Operations, R&D, and other departments to ensure products are efficiently and effectively transferred and integrated into steady-state manufacturing.

The Senior Operations Quality Engineer provides guidance to project teams and business partners, including suppliers, external manufacturers, and external developers, to ensure compliance with company policies and procedures as well as medical device regulations. In addition, they coordinate and execute audits of internal and external processes to ensure compliance to applicable procedures and requirements.

Qualifications


A minimum of a Bachelor's Degree in Engineering or Sciences is required, while Mechanical Engineering degree is preferred. A minimum of 5 years of related experience is required. Demonstrated working knowledge of Risk Management practices, Corrective and Preventative Actions, and regulatory requirements such as FDA QSR's, ISO 13485:2003 is preferred. Demonstrated competency of statistics, sampling strategies, design of experiments, and structured problem solving methodologies is required. Must be able to work independently with general direction, partner with appropriate departments, and communicate effectively with all levels in the organization. Working knowledge of project management tools and techniques is required. Knowledge of reliability engineering is a plus. Knowledge of software validation requirements is a plus. Six Sigma GB or BB certification is preferred. ASQ Certification is also preferred. This position could require up to 20% domestic travel.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-California-Milpitas
Other Locations:North America-United States-California-Redwood City
Organization: Lifescan Inc. (6097)
Job Function: Quality (Eng)