Staff Quality Engineer

BD • San Diego, CA

298d • $124,700 - $205,800

About The Position

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. The Staff Quality Engineer is accountable as Quality Assurance representative to support reagent new product development and/or product and process sustaining activities through the application of Quality engineering skills for medical devices. Products include, but are not limited to IVD liquid and dried antibody. For New Product Development activities, this person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements. This role will support the clinical IVD design and development. For Sustaining Product activities, this person will understand, improve, and control operational processes in order to realize predictable product flow while satisfying established regulatory and BD standards of quality.

Requirements

• Requires a minimum of a Bachelor's Degree in biological science or engineering.
• A minimum of 10 years relevant experience in equipment validation, process validation, and cleanroom facility design and validation.
• ASQ Certified Quality Engineer or equivalent (preferred).
• Extensive knowledge of applicable regulatory requirements.
• Working knowledge and experience with the application of ISO 9001, ISO 13485, ISO 14971, ISO14644 series, ISO 14698 series.
• Expert in statistics.
• Class II / III medical device experience (preferred).
• Knowledge of design control principles (preferred).
• Proficiency in Minitab or other statistical software, MS Excel, and MS Word required.
• Proficiency in written and verbal communication skills.

Responsibilities

• Supports quality activities for the development, implementation, and ongoing support of IVD reagent products and their related processes, equipment, and software.
• 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 project lead for process improvement projects such as Shingi or Kaizen or projects as defined during annual Quality Objectives development.
• Guides the successful completion of major programs and may function in a project leadership role.
• Act as QA lead for facility design, validation controlled non-classified (CNC) manufacturing area.
• Mentor, coach, and guide junior QE team members to enable development of self and others.
• Ensures quality conduct of projects, including design, data summary and interpretation, report preparation and review adherence to applicable regulations.
• Implements and communicates the strategic and technical direction for the product/project team.
• Identifies any issues that may delay product or project and recommends appropriate action to be taken.
• Independently determine options to address issues ensuring quality, and business continuity.
• Provides critical quality engineering direction to projects with respect to generally accepted quality engineering tools/principles, such as root cause analysis, FMEAs, risk mitigation, validation, DOE/other process improvement tools, measurement and measurement systems analysis, sampling, and control plans.
• Demonstrates working knowledge of applicable regulatory, corporate and/or Unit requirements.
• Provides audit support (preparation, closure, etc. activities).
• Acts as site's validation expert or subject matter expert for validation and be able to communicate with external and internal auditors.
• Revises policies/procedures.
• Prepares reports, including quantitative / qualitative analysis, summaries, and protocols.
• 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 projects.
• Performs other tasks assigned by management as required.

Benefits

• Competitive salary range of $124,700.00 - $205,800.00 USD Annual.
• Opportunities for professional development and growth.
• A culture that values opinions and contributions.
• Support for work-life balance.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree