Job Description Summary

The Staff Quality System Specialist I is accountable for support of the continued development,
improvement, and implementation of the Quality Systems. This position actively participates in quality
guidance, product resolution decisions, and project teams for project teams for process improvement and
continuous improvement activities.

Job Description

We are the makers of possible 

 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)

1. Consistent application of Quality System standards to assigned Quality System area.
2. Develops solutions to routine assigned activities of moderate scope & complexity.
3. Follows applicable Company / Unit procedures and may make updates to procedures and policies.
4. Works within and across functions for assigned Quality Systems.
5. Working knowledge of Quality Systems Regulatory requirements and application to Company / Unit requirements.
6. Subject matter expert / Super user at site/plant level for assigned quality system.
7. May perform other duties as required.

Education and Experience:

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

Knowledge and Skills:

• Working knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. - 21 CFR Part 820, ISO 13485, MDSAP, EU MDR/IVDR).
• Able to guide the successful completion of major programs and may function in a project leadership role.
• Ability to provide management with review opportunities for projects and programs at key points and upon completion.
• Can ensure quality conduct of projects, including design, data summary and interpretation, and report and manuscript preparation and review adherence to applicable regulations.
• Can provide decisions, recommendations, and results to further the achievement of goals critical to organizational objectives.
• Able to implement and communicate the strategic/technical direction for the product/project team.
• Can identify any issues that may delay product/project team goals and recommends appropriate action to be taken.
• Can create and support documentation.
• Considered Site Level Subject Matter Expert in both process & IT applications for site for assigned quality system element.
• Experience with BD software systems utilized in the Quality Systems is desirable.
• Experience as an Internal Lead Auditor and/or Supplier Lead Auditor desirable.
• Certified Quality Engineer, Quality Auditor, Transactional Six Sigma Green/Black belt desirable.

Must have knowledge/specialization in one or more of the following areas:

• Calibration
• CAPA
• Complaints
• Computer System Validation
• Continuous Improvement
• Design Controls
• Documentation Management
• EU MDR/IVDR
• Internal Audit
• Label/IFU Controls
• Management Review/Controls
• Nonconforming Material/Processes
• Post-Market Surveillance
• Quality Data Analysis
• Risk Management
• Supplier Quality
• Training

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 availab