BD (Becton, Dickinson and Company) Jobs

Job Description Summary

The Staff Quality Engineer I is accountable for supporting new product development and sustaining engineering projects which support strategic and business priorities. This person will handle projects and tasks, from product inception through product launch and maintenance, and play an active role in the process to ensure products meet quality standards consistent with both Corporate and Unit policies, while meeting all design control and other regulatory requirements.

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 creativity 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 I is accountable for supporting new product development and sustaining engineering projects which support strategic and business priorities. This person will handle projects and tasks, from product inception through product launch and maintenance, and play an active role in the process to ensure products meet quality standards consistent with both Corporate and Unit policies, while meeting all design control and other regulatory requirements.

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)

• Extensive application of technical principles, theories, concepts, techniques, quality sciences, tools, and systems with measurable/confirmed results.

• Track record of root cause determination and effective corrective/preventive action implementation.

• Provides training for product development teams and continuous improvement teams on best practices.

• Conducts audits as a member of a quality system audit team (e.g. – SME, auditor-in-training, auditor, etc.)

• Writes and leads risk management activities including risk management reports and risk analyses.

• Support product development and sustaining project activities which support strategic and business priorities and initiatives.

• May perform other duties as required.

Education and Experience:

• Typically requires a minimum of a bachelor’s degree in science, engineering, or other relevant discipline and a minimum of 8 years relevant experience or a combination of equivalent education and relevant experience.

Knowledge and Skills:

• Extensive knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. - 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, EU MDR/IVDR) as it relates to the design and continued support of BD products.

• Extensive knowledge of applicable Corporate and/or Unit requirements.

• Guides the successful completion of major programs and may function in a project leadership role.

• Able to provide management with review opportunities upon completion.

• Can ensure quality conduct of projects, including design, data summary and interpretation, report and manuscript preparation, and review adherence to applicable regulations.

• Can make decisions, recommendations, and results that further the achievement of goals critical to organizational objectives.

• Able to implement and communicate the strategic and technical direction for the product/project team.

• Can identify any issues that may delay product/project timelines and recommends appropriate action to be taken.

• Able to work under consultative direction toward predetermined long-range goals and objectives.

• Able to create and support policies and procedures.

• Can be considered a site/functional level Subject Matter Expert.

• Able to be assigned as site/functional extended team member.

• Experience with BD software systems utilized in the Quality Systems is desirable.

• Must have knowledge/specialization in one or more of the following areas:

• Acceptance sampling theory and application

• Statistical process control methods and application

• Measurement system/test method knowledge and analysis

• Quality planning

• Failure analysis investigation

• Design of Experiments

• Process mapping and value stream analysis

• Hypothesis testing

• Descriptive statistics

• Process capability analysis

• Basic quality tools: Pareto, box plots, histograms, scatter diagrams, etc.

• Risk Management

• Supplier quality management

• Auditing

• Design/development tools

• Process validation

• Software validation

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.

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 encourage people with the creativity and aim 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.

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift

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.