BD · 1 month ago
Quality Manager - Design Assurance
USA CA - San Diego TC Bldg C&D
Full-time
Onsite
Senior Level, Lead/Staff
$127K/yr - $209K/yr
8+ years expBD is one of the largest global medical technology companies in the world, dedicated to advancing health. The Quality Manager - Design Assurance will lead all quality activities related to the design, development, and transfer of medical devices to manufacturing, ensuring compliance with regulations and quality standards throughout the product lifecycle.
Health CareMedical DeviceTechnical Support
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
Qualification
Required
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)
Preferred
Master's degree
ASQ certifications (e.g., CQE, CMQ/OE, CRE) are highly desirable
Benefits
A valuable, competitive package of compensation and benefits programs
Company
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
10001+ employees
H1B Sponsorship
BD has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$540MKey Investors
Steris
2023-08-02Post Ipo Equity· $540M
1962-04-23IPO
Leadership Team
Tom Polen
Chairman, CEO and President
Richard Byrd
Executive Vice President and President of the BD Interventional Segment
Recent News
EIN Presswire
2026-01-09
Company data provided by crunchbase