Becton, Dickinson and Company

Staff Quality Systems Specialist I

Becton, Dickinson and Company • $135K — $216K *
Franklin Lakes, NJ 07417In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
1 week ago
Job Overview by Ladders

Qualifications

  • BS degree in Engineering, Science, or related discipline.
  • Minimum 8 years of experience in medical device, biologic, pharmaceutical, or diagnostic industries.
  • Strong understanding of US and International medical device regulations (21CFR820, ISO 13485, MDD/MDR).
  • Proven communication, organizational, and interpersonal skills.
  • Demonstrated ability in analytical, technical, and problem-solving.

Responsibilities

  • Develop and update Site / Unit procedures and work instructions.
  • Lead site CAPA activities as the Subject Matter Expert and facilitate CAPA Board meetings.
  • Manage audits and collaborate with Audit Program Manager to meet internal audit requirements.
  • Coordinate Quality Notifications and guide end users in processing them.
  • Support problem-solving and root cause analysis for quality issues.
  • Analyze quality data trends and report on relevant metrics.
  • Collaborate with cross-functional teams to enhance policies and address Quality Issues.

Benefits

  • On-site collaboration fosters creativity and innovation.
  • Minimum of 4 days in-office presence to maintain operational excellence.
  • Support for work-life balance while ensuring flexibility.
  • COVID-19 vaccination proof may be required for employment.
Full Job Description
Job Description

Job Responsibilities:
  • Develops applicable Site / Unit procedures / work instructions and may make updates to Unit level procedures and policies.
  • Serves as the Site CAPA Leader
    • Acts as Subject Matter Expert to CAPA end users regarding CAPA content and Trackwise utilization.
    • Leads site CAPA Board meetings and liaises with the WW CAPA Board to ensure timely completion of CAPA activities and identify areas of improvement/escalation
  • Serves as the site Audit Manager
    • Collaborates with the PS Internal Audit Program Manager to assess risks and ensure site internal audit requirements are met
    • Ensures systematic execution of all required internal, external (FDA, ISO, etc.) and customer audits
    • Supports pre- and post-inspection activities, which may include but are not limited to hosting and logistics, coaching subject matter experts, record review, and tracking of responses, actions and other audit closure activities.
    • Acts as Subject Matter Expert regarding audit process and electronic tools utilization.
  • Serves as the site coordinator for Quality Notifications (NCs and Planned Deviations)
    • Acts as Subject Matter Expert regarding QN content, process, and electronic tools utilization
    • Supports end users in meeting timely completion of QN related activities
  • Leads or supports problem-solving and root cause analysis activities, as needed. Coaches cross-functional teams as a problem-solving subject matter expert.
  • Tracks trends of various Quality Data sources (CAPA, Audits, QNs, etc.). Analyzes and reports on metrics.
  • Assists with Management Review content development and related activities.
  • Maintains Site and WW Quality Systems. Supports continuous improvement initiatives.
  • Collaborates with cross-functional partners such as Quality Engineering, R&D, Operations, Medical, Marketing to seek their input into the development of policies and procedures, and their support in addressing Quality Issues.


Education and Experience:
  • BS degree in in Engineering, Science, or other related discipline
  • At least 8 years of medical device, biologic, pharmaceutical, or diagnostic industry experience.


Knowledge and Skills:
  • Strong knowledge of US and International regulations and standards that apply to the medical device industry including 21CFR820, ISO 13485, MDD/MDR, MDSAP country requirements as well as other requirements applicable to the product.
  • Proficient communication, organizational and interpersonal skills.
  • Ability to perform multiple tasks and prioritize workload. Self-motivated / directed, require minimum supervision
  • Effective analytical, technical, and problem-solving skills.
  • Effective meeting and presentation skills.
  • Ability to perform and/or host internal / external audits.
  • Collaborative ability to work in teams to obtain desired results.


At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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.

Primary Work Location
USA NJ - Franklin Lakes

Salary Range Information
$135,500.00 - $216,800.00 USD Annual

About Becton, Dickinson and Company

BD is a global technology company that provides diagnostics and technologies for frontliners. Through their solutions and services, they assist scientists in detecting diseases and advanced researchers' on developing diagnoses and therapeutics. BD was established in 1897 by Farleigh Dickinson and Maxwell Becton in East Rutherford, New Jersey.

Becton, Dickinson and Company Careers

Join the innovative world of Becton, Dickinson and Company (BD), a global medical technology company that is actively seeking driven, dedicated professionals to join our team. At BD, we are committed to advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. This commitment provides the foundation for a workplace where you can engage in meaningful work and where job opportunities abound.

Work You’ll Do

At BD, you will be part of a culture that values diversity, leadership, and innovation. Our team members are empowered to lead and inspire from day one. Join us and contribute to our mission of advancing the world of health through your professional skills and personal passion.

Transform Your Career

BD offers a unique position in the marketplace that combines industry expertise, leadership in medical innovation, and a collaborative culture to help you grow your career. Whether you are looking for an entry-level position or a more senior role, we provide the tools and support for your professional growth through comprehensive training and development programs.

Innovative Work Environment

Our team at BD is composed of more than 65,000 associates across the globe. These dedicated professionals work at the intersection of technology and healthcare, where they drive innovation and ensure that we stay ahead in a rapidly evolving industry. By joining BD, you will work alongside some of the brightest minds in the industry.

Internship and Employment Opportunities

Start your career with BD through our internship programs or dive straight into a full-time position. We offer a range of opportunities that allow you to explore different areas of our business and find a path that aligns with your career goals. Our hiring process is designed to be transparent and engaging, ensuring that all candidates—whether submitting a resume for an internship or a senior position—feel valued and informed.

Benefits and Culture

BD is proud to offer competitive benefits that support the health, well-being, and financial security of our employees and their families. From comprehensive health insurance to employee wellness programs and flexible working arrangements, we prioritize the well-being of our team members. Our inclusive culture encourages networking, continuous learning, and the sharing of ideas in a diverse and welcoming environment.

Join Our Team

Explore the job opportunities at BD and discover how your expertise can help shape the future of healthcare. Search open positions that match your skills and interests. We look for passionate, curious, creative, and solution-driven team players.

Stay Connected

Keep up to date with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. See what exciting and rewarding opportunities await at Becton, Dickinson and Company.

Explore Careers at BD

Whether you're preparing for your first interview or looking to advance into a leadership role, BD offers career paths that foster continuous growth and innovation. Join us in our mission to improve medical outcomes and enhance patient care worldwide.

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At Becton, Dickinson and Company, we are more than just a company; we are a community that is dedicated to making a difference in the lives of people all around the world.
Learn more about Becton, Dickinson and Company
Size
75,000 employees
Market Cap
$72 billion
Industry
Healthcare
Net Income
$1.6 billion
Founded
1897
5 Year Trend
+9.3%
Revenue
$18.2 billion
NASDAQ
BDX
* Ladders Estimates

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