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BD (Becton, Dickinson and Company) Staff Quality Engineer in San Diego, California

Job Description Summary

The Staff Quality Engineer is accountable for supporting the Risk Management Program, Post Market Surveillance quality engineering activities, and new and sustaining product development. This person will handle projects and tasks 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 quality and regulatory requirements.

Job Description

Be part of something bigger!

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

Primary Duties and Responsibilities:

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

  • Carries out activities in support of Risk Management Program and Quality Engineering for the Unit Quality Program.

  • Work with cross function team members to support sustaining and new product development.

  • Participate as an active project core team member and support all related activity.

  • May perform other duties as required.

Knowledge/Skills:

  • 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 alignment to applicable laws.

  • 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 SME.

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

  • Experience with BD software systems used 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

Education and Experience:

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

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 empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do 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. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.

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

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.

PDN

Primary Work Location

USA CA - San Diego TC Bldg C&D

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.

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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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