Quality Engineer; Process Validations

Overview

Job Description Summary The Staff Quality Engineer reports to the Plant Quality Head, BD Biosciences (BDB) Business Milpitas Unit and is responsible for providing critical quality engineering direction to projects with respect to generally accepted quality engineering tools/principles, such as design and process validation, measurement systems analysis, equipment and software validation. This role will be a Core Team member, or extended team member representing Site Quality on new product development and sustaining projects, will oversee the transfer of the new product and change to manufacturing.

An individual in this position will work actively with the suppliers to transfer test methods and establish acceptance criteria for complex subassemblies. The position implements policies to ensure compliance with applicable US federal regulations, California state requirements, and global regulations.

We are the makers of possible. BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

• Lead Facilities, Process, Test Method, Equipment, and Software Validations (IQ, OQ, PQ) for new product introduction and sustaining engineering projects
• Provide critical quality engineering direction to projects with respect to generally accepted quality engineering tools/principles, such as design and process validation, measurement systems analysis, equipment and software validation, root cause analysis, FMEAs, risk mitigation, DOE/other process improvement tools, sampling and control plans
• Apply technical principles, theories, concepts, techniques and quality sciences/tools. Follow company procedures and make procedural updates
• Demonstrate working knowledge and application of applicable regulatory, Corporate and/or Unit requirements
• Act as Core Team member or extended team member representing Site Quality on new product development projects and a team member for sustaining engineering projects
• Act as Quality Assurance reviewer/approver or author for documentation such as protocols and reports, deviations, and design history files
• Establish strong working relationships with all levels of operations to monitor and analyze in-process inspection, process control activity, waste and reject rates, PM compliance, environmental control and customer complaint levels; lead continuous improvement projects
• Support appropriate CAPA activities to accomplish internal/external objectives
• Mentor associates in Quality system concepts and documentation

• Staff QE should possess strong knowledge of process validations and production and process controls
• Excellent leadership, communication, organization and project management skills
• Ability to make timely critical decisions regarding product quality and/or quality system compliance
• Expert understanding of quality engineering sciences and their application to validation activities
• Thorough understanding of 21 CFR 820, MDSAP, ISO 13485, ISO 9001 and ISO 14971
• Ability to prepare and understand technical documentation such as Engineering Drawings, Operating Procedures, Work Instructions, Technical/Validation Studies, etc.
• Ability to assess and articulate risk when evaluating a situation
• Ability to perform thorough investigations, identify root causes, and propose appropriate corrective actions
• Strong written and oral communication, organizational skills, and ability to work independently or in teams

• Typically requires a bachelor’s degree in science, engineering, or other relevant field and 5 years relevant experience or a combination of equivalent education and relevant experience

• ASQ certification desired

• A minimum of 5…