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

Job Description Summary

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.

Job Summary:

As directed by the Quality Manager, the Staff Quality Engineer I is accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices. 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 can be a home-based REMOTE or HYBRID role!

Accountabilities:

  • Develop and implement reliability analysis, design, validation and assessment methods to support successful new product introductions and or sustaining product changes

  • Provide quality leadership to new product development teams in the areas of design control, design verification and validation, design transfer, process validation, risk management, and specification development.

  • Drive product risk management activities and ensure quality and completeness of project design history files, validation packages, and change orders

  • Provide ongoing quality engineering support throughout the product life cycle. Provide support to development, engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs strategies and requirements. Ensure product development and validation programs meet requirements of FDA and ISO when applicable

  • Work with Engineering and R&D to develop reliability testing plus modeling methods specific to products and systems for HALT, Shock and Vibration, Weibull, MTBF and others as required

  • Set Reliability goals for products and their subsystems in the field and measure against progress. Maintain a knowledge base of lessons learned to enable continuous improvement

  • Manage and assess reliability risks that could adversely affect operations by providing analysis, diagnostics, and reporting. This will involve data analysis techniques to help companies meet accepted reliability standards.

  • Writes detailed Risk Assessments, updates Process Hazard Analysis, and present analysis to the Risk Management Board

  • Trend, analyze, and report on quality data in order to improve product and process; develop recommendations based on data analysis

  • Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion

Qualifications:

  • Bachelor’s Degree in Mechanical, Electrical, Reliability Engineering, or related field.

  • Minimum 10+ years’ experience in quality assurance field in a regulated environment

  • Minimum 6+ years’ experience in medical device industry

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

  • Knowledge of medical device regulations (FDA 21CFR80.820, ISO13485, ISO14971)

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

  • Ability to effectively lead and influence cross functional teams.

  • Strong problem identification and problem solving abilities.

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.

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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