Staff Quality Engineer (Process Validations)

Becton Dickinson Medical Devices • Milpitas, CA

1d • Onsite

About The Position

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’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. 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.

Requirements

• Staff QE should possess strong knowledge process validations and production and process controls
• An individual in this role must have excellent leadership, communication, organization and project management skills.
• The ability to make timely critical decisions regarding product quality and/or quality system compliance.
• An expert understanding of quality engineering sciences and their application to Validation activities
• A thorough understanding of 21 CFR §820, MDSAP, ISO 13485, ISO 9001 and ISO 14971.
• The ability to prepare, and understand technical documentation such as Engineering Drawings, Operating Procedures, Work Instructions, Technical/Validation Studies, etc.
• The ability to assess and articulate risk when evaluating a situation.
• The ability to perform thorough investigations, identify root cause(s) of an issue, and propose appropriate corrective action(s).
• The ability to communicate effectively in writing and orally, to organize work, and to achieve results when working alone 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.
• A minimum of 5 years of quality assurance or relevant experience.
• Experience should be in the Medical Device or Bioscience industry.
• Significant experience in Process validation, FDA regulations and ISO requirements.
• Good communication and presentation skills, Project Management, Trackwise systems, SAP.
• Maintains positive and cooperative communication and collaboration with all levels of employees, customers, contractors, and vendors.
• Knowledge of US and International regulations and standards that apply to the in vitro diagnostic and medical device industry, including FDA Quality Systems Regulations, MDSAP, ISO 13485 & 9001, ISO 14971, In-depth understanding of the application of QS to the medical device industry.
• Must be able to balance a complex agenda, ability to multitask.
• Must be well organized and methodical.
• Partners with cross-functional stakeholders to drive resolutions
• Works across BDX to share improvements and learn from others on areas for potential improvements.

Nice To Haves

• ASQ certification desired.

Responsibilities

• Lead Facilities, Process, Test Method, Equipment, and Software Validations (IQ, OQ, PQ) for new product introduction and sustaining engineering projects
• Provides 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.
• Applies technical principles, theories, concepts, techniques and quality sciences / tools.
• Follows company procedures and makes procedural updates
• Demonstrates working knowledge and application of applicable regulatory, Corporate and/or Unit requirements.
• Is a Core Team member, or extended team member representing Site Quality on new product development projects and a team member for sustaining engineering projects.
• Acts as Quality Assurance reviewer/approver or author for documentation such as protocols and reports, deviations, and design history files.
• Establishes a strong working relationship with all levels of operations in order to appropriately monitor and analyze in-process inspection, process control activity, and waste and reject rates, PM compliance, environmental control and customer complaint levels in order to take a lead role in identifying and documenting continuous improvement project
• Supports appropriate CAPA activities to accomplish internal/external objectives.
• Mentor associates in Quality system concepts and documentation.

Benefits

• At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You .
• Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level