Becton Dickinson (BD) is hiring a Quality Manager - Design Assurance

BD is looking for a Quality Manager - Design Assurance to 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.

What You'll Do

• 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.

What We're Looking For

• 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.
• 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.
• Experience with various quality tools and methodologies (e.g., FMEA, SPC, Root Cause Analysis).

Nice to Have

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

Team & Environment

You will manage the Design Quality and Risk functions within the Infusion platform.

Benefits & Compensation

• Annual compensation range: $126,600.00 - $208,900.00 USD

Work Mode

This is a hybrid role based in San Diego, CA (USA CA - San Diego TC Bldg C&D).

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate 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.