Senior Quality Systems Specialist

We are the people who give possibilities purpose

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 Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

The Sr. Quality System Specialist 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.

• Consistent application of quality system standards to assigned quality system area.
• Develops solutions to routine assigned activities of moderate scope & complexity.
• Follows applicable Company/Unit procedures and may make updates to procedures and policies.
• Works within and across functions for assigned quality systems.
• Working knowledge of quality systems regulatory requirements and application to Company/Unit requirements.
• Can ensure quality conduct of projects, including design, data summary and interpretation, and report generation for self and lower level project developers.

• Bachelor’s degree in science, engineering, or other relevant discipline
• 5 years of relevant experience

• Experience with BD software systems utilized in the Quality Systems
• Certified Quality Auditor or Transactional Six Sigma Green Belt

• 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).
• Working knowledge of applicable Corporate and/or Unit requirements
• Able to revise policies and procedures.
• Can independently determine and develop approach to solutions.
• Can develop solutions to routine assigned activities of moderate scope & complexity.
• 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 available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

At BD, we are committed to supporting our associates’ well-being, development, and success through a performance-based culture. For this position, BD offers a competitive compensation package along with the following benefits specific to this role:

• Annual Bonus
• Potential Discretionary LTI Bonus

• Medical coverage
• H…