Job Description Summary

The Staff Quality Engineer is accountable for leading Distribution Quality projects and represent Distribution Quality on broader project core teams owned by other business units/functions or central teams. Represent Quality’s interests as it relates to project scope, requirements, design, build, change management, and implementation. Create the Quality components of the overall project plan. Works with Quality and Operations to ensure resources are available to execute project plans to meet budget and timeline expectations in an efficient and effective manner.

Job Description

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.

Duties and Responsibilities

• Lead Distribution Quality projects by serving as the Project manager as well as the Quality representative on the team. Follow effective project management practices regarding creating charters, ensuring proper core team representation and accountability, developing and executing project/quality plans, project status reporting, change management and project close-out

• Represent Distribution Quality as a core team member of broader projects. Serve as a conduit to ensure Distribution Quality’s interest are represented when it comes to the project charter, requirements, design, build, and implementation. Keep Distribution Quality informed of project goals, progress, and issues.

• Develop the Distribution Quality portion of the overall project plan, including clear milestones, and oversee/coordinate its execution. As required, take an active role in the actual deliverables. Ensure Quality resources are available and aligned to project plans and that deliverables are on time and on budget

• Track and report on project and execution metrics. Ensure issues are proactively identified, communicated, and addressed using contingency planning and effective problem resolution skills.

• Ensure compliance and a standardized approach to applicable requirements of ISO 13485, 21 CFR 820, Corporate and regional NASC Quality Standards.

• Provides coaching, mentoring, and training for project team and peers. Provide feedback on team members as requested by managers for performance discussion purposes

• Develops complex validation protocols based on business and operations needs, strategies, and requirements.

• Modifies methodologies and procedures, ensuring continuous improvement of desired outcomes.

• Extensive knowledge of quality engineering principles (e.g. acceptance sampling, statistical process control, measurement/test methods, quality planning, failure investigation, design of experiments, process FMEA, value stream mapping, hypothesis testing, descriptive statistics, process capability)

• Ensure effective implementation and execution of Quality processes conducted under the Quality Systems to accomplish expected requirements and performance.

• Utilize metrics and reporting to effectively monitor processes, report on performance, drive improvement, and provide cost savings to the business.

• Employ and share best practices and tools to accelerate continual quality improvement into DC organization locally and across the region, initiating lessons learned and best practice concepts; to introduce pro-active improvement and prevent recurrence of issues.

• Maximize the benefits for the overall system to drive Business, Supply Chain performance and customer satisfaction.

Education/Requirements:

• Bachelor's degree with 8 years experience or Master's degree with 6 years experience in medical device industry, preferred

• Minimum of 5 years of project management experience including a minimum of two years leading projects, experience being a core team member, and accountability for project execution.

• Minimum of 3 years working in, or closely with, a Quality function; distribution Quality preferred

• Quality Certification preferred (e.g., CQE)

• Knowledge of medical device regulations (FDA 21CFR80.820, ISO13485, ISO10993)

• Results orientation with strong written and oral communications skills to lead cross-functional teams.

• Strong problem identification and problem-solving abilities.

Competencies:

• Knowledge, and demonstrated application, of project leadership, management, and governance best practices.

• Ability to lead and/or participate in teams and address problems/issues through effective communication skills, creative problem solving, influence, negotiation or conflict management skills. Rarely calls upon others to help solve organizational roadblocks

• Knowledge of, and ability to apply ISO 13485, 21 CFR 820, Corporate and regional NASC Quality Standards.

• Working knowledge to effectively work across multiple departments (e.g. Operations, TGS, Customer Service, Regulatory, etc.)

• Ability to identify, mitigate and resolve problems and issues

• Ability to work in a matrix environment

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.

To learn more about BD visit https://bd.com/careers

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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Primary Work Location

USA CA - San Diego TC Bldg C&D

Additional Locations

USA CA - San Diego - Otay Mesa

Work Shift

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 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. There are many factors, such as location, that contribute to the range displayed. The salary offered to a successful candidate is based on experience, education, skills, and actual work location. Salary ranges may vary for Field-based and Remote roles.

Salary Range Information

$121,100.00 - $199,800.00