Manager, Quality

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The Quality Manager will lead and oversee all aspects of the Quality Management System (QMS) and Risk Management for the Alaris System. This role is responsible for ensuring compliance with regulatory requirements, company policies, and industry standards, driving continuous improvement initiatives, and maintaining a culture of quality throughout the organization.

• QMS Leadership and Management:
  • Develop, implement, and maintain the Quality Management System (QMS) in accordance with ISO 13485, 21 CFR Part 820 (QSR), and other applicable global regulations and standards.
  • Lead and manage a team of quality professionals, providing guidance, coaching, and performance feedback.
• Quality Improvement And
  
  Risk Management:
  
  
  • Drive continuous improvement initiatives through data analysis, root cause investigation, and implementation of effective CAPAs.
  • Facilitate risk management activities, including FMEAs and risk assessments, throughout the product lifecycle.
  • Oversee non-conformance and deviation management processes.
  • Promote a strong quality culture through training, communication, and engagement across all departments.

• Education:
  • Bachelor's degree in Engineering, Life Sciences, or a related field. Master's degree preferred.
• Experience:
  • Minimum of 5 years of experience in Quality Assurance within the medical device industry.
  • Minimum of 3 years of experience in a leadership role, preferred.
  • In-depth knowledge and practical experience with ISO 13485, 21 CFR Part 820 (QSR), MDR, and other relevant global medical device regulations.
  • Proven experience in managing and developing quality teams.
  • Demonstrated success in leading regulatory audits (e.g., FDA, Notified Body).
• Skills:
  • Strong analytical and problem-solving skills with a data-driven approach.
  • Excellent written and verbal communication skills, with the ability to effectively interact with all levels of the organization and external stakeholders.
  • Proficient in quality tools and methodologies (e.g., Lean, Six Sigma, FMEA, Root Cause Analysis).
  • Strong leadership and interpersonal skills, with the ability to influence and motivate others.
  • Proficiency in Microsoft Office Suite and QMS software.
• Certifications (Preferred):
  • ASQ Certified Quality Manager (CQM), Certified Quality Engineer (CQE), or equivalent.

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 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.

A career at BD means being part of a team that values your opinions and contributions and encourages you to bring your authentic self to work. It’s also a place where we help each other be great, do what’s right, hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do.

We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

To learn more about BD, visit https://

Equal Opportunity

Employer:

Becton, Dickinson, and Company evaluates applicants without regard to 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, and other legally-protected characteristics.

Mid-Senior level

Full‑time

Quality Assurance

Manufacturing

$ - $ USD Annual