Quality Manager - Design Assurance

Becton Dickinson Medical Devices • San Diego, CA

1d • Onsite

About The Position

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 Summary: The Quality Manager - Design Assurance will lead and manage all quality activities related to the design, development, and transfer of medical devices to manufacturing. This role ensures compliance with all applicable regulations, standards, and internal quality system requirements throughout the product lifecycle.

Requirements

• Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical, or related field) or a scientific discipline.
• Minimum of 8 years of experience in Quality Assurance within the medical device industry, with at least 2-3 years in a leadership or management role focused on Design Assurance.
• Extensive knowledge and practical application of medical device regulations and standards, including FDA 21 CFR Part 820 (QSR), ISO 13485, ISO 14971, and EU Medical Device Regulation (MDR).
• Demonstrated experience with product development, design controls, and design verification/validation methodologies.
• Expertise in product risk management and hands on experience developing and maintaining a Product's Risk Management File.
• Proven ability to recruit, lead, motivate, and develop a team of quality professionals.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent written and verbal communication skills, with the ability to effectively communicate complex technical and regulatory information.
• Experience with various quality tools and methodologies (e.g., FMEA, SPC, Root Cause Analysis).

Nice To Haves

• Master's degree preferred.
• ASQ certifications (e.g., CQE, CMQ/OE, CRE) are highly desirable.

Responsibilities

• Lead and manage a team of Design Assurance engineers, providing guidance, mentorship, and performance management.
• Develop, implement, and maintain design control procedures, ensuring compliance with FDA QSR, ISO 13485, MDR, and other relevant regulatory requirements.
• Act as the primary Quality representative on new product development and sustaining engineering projects, ensuring quality is built into the design process.
• Oversee the generation and review of design input requirements, design outputs, design reviews, design verification and validation plans and reports.
• Manage risk management activities throughout the product lifecycle, including FMEA, hazard analysis, and risk management files.
• Ensure the effective transfer of design to manufacturing, including process validation, DHF completeness, and production control plans.
• Participate in internal and external audits, including FDA inspections, Notified Body audits, and customer audits.
• Drive continuous improvement initiatives within the Design Assurance function and across the Quality Management System.
• Collaborate cross-functionally with R&D, Regulatory Affairs, Manufacturing, and other departments to ensure product quality and regulatory compliance.
• Develop and deliver training on design control and quality system processes.
• Manage supplier quality activities related to design and development, including supplier qualification and monitoring.

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.
• There are many factors, such as location, that contribute to the range displayed.
• The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position.
• Salary or hourly pay ranges may vary for Field-based and Remote roles.

What This Job Offers

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