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BD (Becton, Dickinson and Company) Senior Quality Engineer (Hybrid) in Salt Lake City, Utah

Job Description Summary

As directed by the Quality Manager, the Sr. Quality Engineer will be a member of the Advanced Access Devices (AAD) platform and is accountable for 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.

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.

The Sr. Quality Engineer is accountable for quality support for devices, products developed and process design to achieve these goals through active participation and contribution to multifunctional and multi-divisional teams. The incumbent will be capable of self- direction and project management to ensure successful outcomes.

Schedule : Monday - Friday, 8:00 AM - 5:00 PM. Hybrid schedule - working 3 days in office/onsite at Salt Lake City and 2 days remote.

Key Responsibilities:

  • Provide guidance and Quality oversight to ensure establishment and execution of robust design programs aligned with regulatory requirements and industry standards.

  • Support new product development and existing product sustaining activities to ensure work follows proper design control. Ensure controls meet BD and FDA regulatory requirements by actively participating on product development teams and identifying Quality needs, product improvements and customer requirements.

  • Ensures adequate design control documentation and records are maintained to support life cycle of design history.

  • Lead and support new product development execution of design control and ensure tasks are completed adequately to include project planning, design inputs, critical to quality characteristics, risk analysis, design reviews, validations, verifications, and design history files and other activities as needed.

  • Responsible to evaluate design verification results and data utilizing statistical analysis to ensure design delivers an acceptable quality level during manufacturing with properly established product specifications.

  • Ensures the design is appropriately specified and established before transferring into manufacturing to avoid increased risk.

  • Review and authorize Quality approval for new product and/or device design specifications including product performance specifications, test methods, acceptance criteria, and release.

  • Support product and/or device continuous improvement initiatives by providing quality and regulatory requirements, approving protocols, assessing generated data and approving final reports.

  • Review and assess work performed by R&D and other BD business units to help ensure Quality issues with device(s) or component(s) are adequately addressed and when needed corrective actions are taken to prevent recurring quality issues.

  • Work with Validation team providing Quality Engineering support for Product and/or Device transfer, Scale-Up, and Process Validation.

  • Lead or participate in ISO 14971 Risk Management activities appropriate to the initiative or situation.

  • Monitor quality data from Product Incident Report process, Manufacturing reports, Service reports and customer input. Identifies, investigates, troubleshoots and resolves identified quality issues independently or by working with Manufacturing, Service, Engineering, Regulatory and Biostatics.

  • Initiate Corrective and Preventative Action plans and perform efficacy follow up.

  • Conduct as needed supplier evaluations and meet with suppliers to establish required controls to meet BD and regulatory requirements.

  • Participate as assigned with supplier capability and internal audits as a means of evaluating effectiveness of GMPs and established Quality Systems.

  • Support Regulatory Affairs, as appropriate, by providing input for submissions or response to agency queries.

  • Support regulatory inspections as needed.

  • Support activities relating to Field Corrective Actions, when needed.

  • Provide guidance quality and training to other quality engineer to help increase knowledge of regulations and standards for Devices and Combination Products.

Qualifications:

  • Bachelor’s degree in STEM and six (6) years of engineering experience within a regulated industry,

  • OR Master’s degree in STEM and four (4) years of engineering experience within a regulated industry required,

  • American Society of Quality (ASQ) certification (CQE, CQA, etc) preferred.

  • Experience in medical device industry strongly preferred.

  • Demonstrated knowledge of engineering principles through engineering experience including three (3) years of proven and effective project management skills.

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 UT - Salt Lake City BAS

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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