Job ID R-412829 Date posted 09/16/2021

Be part of something bigger at BD. Here, you’ll help us continually improve how we do things every day; to be more efficient, more effective and better serve our customers. You’ll do this within an exceptional team all striving to make sure that everything we do complies with regulations and standards, not just because it’s the right thing to do, but because our products impact people’s quality of life. Here, you’ll put your compliance experience, high expectations and attention to detail to the very best use: advancing the world of health™. At BD, you can make a true difference of one.

  • Job Type:
    Full-Time
  • Job Level:
    Entry to Senior
  • Travel:
    Varies
  • Salary:
    Competitive
  • Glassdoor Reviews and Company Rating

Responsibilities

Job Description Summary

Reporting to the Assoc Director of Quality, this position will support Quality Compliance functions within BD Bioscience (BDB) Quality Systems. Maintains the vital quality programs to ensure the BDB Unit meets the Quality System requirements per BD procedures and applicable federal laws and international standards.
Values – Our Standard of Behavior


• We do what is right
• We thrive on innovation and demand quality
• We are all accountable
• We learn and improve every day
• We help each other be great

Our Mindset – The attitude we bring to our work



• Speaking up builds trust and gets to better outcomes faster
• Inclusion and diversity make us a stronger team
• Keeping it simple enables innovation and agility
• The best way to help customers and patients is to truly know them
• Challenges are opportunities to grow and improve

Leadership Commitments – How we lead ourselves and our work


• Be bold and strategic
• Remove obstacles and empower others
• Deliver results that matter
• Debate and decide, then commit and go
• Have the courage to iterate, try new things and embrace change

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.

Reporting to the Assoc Director of Quality, this position will support Quality Compliance functions within BD Bioscience (BDB) Quality Systems.  Maintains the vital quality programs to ensure the BDB Unit meets the Quality System requirements per BD procedures and applicable federal laws and international standards.

Values – Our Standard of Behavior

  • We do what is right 

  • We thrive on innovation and demand quality

  • We are all accountable

  • We learn and improve every day

  • We help each other be great

Our Mindset – The attitude we bring to our work

  • Speaking up builds trust and gets to better outcomes faster

  • Inclusion and diversity make us a stronger team

  • Keeping it simple enables innovation and agility

  • The best way to help customers and patients is to truly know them

  • Challenges are opportunities to grow and improve

Leadership Commitments – How we lead ourselves and our work

  • Be bold and strategic

  • Remove obstacles and empower others

  • Deliver results that matter

  • Debate and decide, then commit and go

  • Have the courage to iterate, try new things and embrace change

PRIMARYRESPONSIBILITIES

  • Execute and coordinate activities associated with Quality System requirements including, but not limited to, CAPA, and Employee Qualification/Training. Serve as site CAPA and Training Coordinator.

  • Lead all aspects of the corrective and preventive action system (CAPA) including analyzing the proposed actions in order to verify that the realized solutions will be effective; determining if the scope of the action is broad enough; and providing collaborative feedback to CAPA owners.

  • Lead functional groups to resolve root cause failure using standard failure analysis tools.

  • Maintain systems for supervising CAPAs and audit findings, perform trending analysis activities, and present information as appropriate to management.

  • Host CAPA Review Board meetings.

  • Establish and maintain effective Training Programs and Processes to assure that associates within all assigned sites are equipped with the knowledge, understanding and training to successfully execute their responsibilities to the highest of standards.

  • Institute a robust training framework covering:

Learning Platform

  • Learning Management System (LMS) setup

  • Structured curriculum, with clear alignment to function and role

Ongoing Trainings

  • Ensure that all aspects of the Training Programs are compliant to all applicable regulations and standards as well as internal policies and processes.

  • Analyze and assess the performance strength of training practices and processes and maintain a keen understanding of training trends, developments and standard methodologies.

  • Participates in regulatory compliance audits and inspections.

  • Assist in developing integrated implementation strategies for assigned QMS elements.

  • Ability to bench mark industry trends for assigned QMS element and apply results.

  • Liaisons with Segment and Corporate on behalf of BDB, as necessary.

EDUCATION AND EXPERIENCE REQUIREMENTS

  • Bachelor’s Degree required; preferably in Science, Engineering or Statistics.

  • 7+ years of experience in quality systems/engineering, preferably in the medical device, pharmaceutical or biotech industry or 5+ years of experience with Master’s degree

  • Proven understanding and application of quality tools, methodologies, and software (i.e., Is/Is Not Analysis, 5 Whys, Cause and Effect Diagram, Process Mapping, Pareto Analysis, Minitab, etc.) in the areas of investigations and CAPAs.

  • Applied Knowledge of the requirements of FDA QSR, ISO13485:2016 & MDSAP, EU MDR/IVDR and ISO 14971:2019 for medical devices.

  • Working knowledge of Trackwise, SAP or other similar systems is preferred  

  • Proficiency in common computer applications such as Microsoft Office (Excel, Word and PowerPoint).

  • Good interpersonal and phenomenal teammate skills including ability to work well with high degree of tact with representatives from a variety of fields.

  • Ability to work in a fast-paced, technically exciting environment where drive is critical to success.

  • Self-motivated, self-disciplined and able to prioritize and balance multiple tasks and responsibilities.

  • Willing to accommodate travel as needed.

  • ASQ CQA, CQE certification preferred.

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 Jose

Additional Locations

Work Shift

NA (United States of America)
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Success Profile

What makes a successful Quality Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.

  • Ambitious
  • Collaborative
  • Goal-oriented
  • Persuasive
  • Results-driven
  • Self-starter

Advancing the world of health™

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. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.

BD is unique in how fully dedicated it is to a specific disease state. It makes it clear how the work we do directly impacts the daily lives of the patients we serve.


Eric Rainis
Senior Director Quality Management

To know that our products touch 30 million people with diabetes around the globe is powerful and fuels our teams to deliver best in class products to them each and every day.


Bridget Bagnato
VPGM Injection

It is inspiring to see BD products to be used globally to advance human healthcare.


Yang Zeng
Manager Medical Laboratory

BENEFITS

Healthcare

401(k)/
Retirement Plans

Professional Development

Paid Time Off

Awards &
Recognition

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San Jose

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