Manager, Quality

Becton Dickinson Medical Devices • San Diego, CA

1d • Onsite

About The Position

The Quality Manager will lead and oversee all aspects of execution of the Quality Management System (QMS), including 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.

Requirements

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• 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).
• 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.

Nice To Haves

• Master's degree preferred.
• ASQ Certified Quality Manager (CQM), Certified Quality Engineer (CQE), or equivalent.

Responsibilities

• 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.

Benefits

• At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture.
• We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You .
• Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees