BD · 8 hours ago
Director, Quality Engineering
USA CA - San Diego TC Bldg C&D
Full-time
Onsite
Director/Executive
$179K/yr - $322K/yr
10+ years expBD is one of the largest global medical technology companies in the world, dedicated to advancing health. The Director, Quality Engineering will strategically lead the quality engineering function, ensuring that medical devices meet high standards of safety, efficacy, and regulatory compliance while fostering a culture of quality throughout the product lifecycle.
Health CareMedical DeviceTechnical Support
Responsibilities
Develop and implement a comprehensive quality engineering strategy aligned with business objectives and regulatory requirements (e.g., FDA, ISO 13485)
Lead, mentor, and develop a team of quality engineers, fostering a high-performance culture and ensuring effective resource allocation
Oversee the application of quality engineering principles in product design and development, including design controls, risk management, and design validation activities
Drive continuous improvement initiatives for manufacturing processes, identifying and addressing quality issues through root cause analysis, corrective and preventive actions (CAPA), and statistical process control
Collaborate with procurement and R&D to establish and maintain a robust supplier quality program, including supplier selection, auditing, and performance monitoring
Ensure all quality engineering activities adhere to applicable regulations and standards, preparing for and supporting internal and external audits
Provide quality engineering support throughout the entire product lifecycle, from concept to post-market surveillance
Partner effectively with R&D, Manufacturing, Regulatory Affairs, and other departments to integrate quality into all aspects of product development and operations
Establish and monitor key quality metrics, providing regular reports to senior leadership on quality performance and trends
Qualification
Required
Bachelor's degree in Engineering (e.g., Biomedical, Mechanical, Electrical, Industrial) or a related scientific discipline required
Minimum of 10 years of progressive experience in Quality Engineering within the medical device industry, with at least 5 years in a leadership or management role
In-depth knowledge of medical device regulations and standards, including FDA 21 CFR Part 820, ISO 13485, and relevant international regulations
Proficiency in quality tools and methodologies such as FMEA, SPC, MSA, Root Cause Analysis, CAPA, and statistical techniques
Proven ability to lead, motivate, and develop high-performing teams
Excellent interpersonal and communication skills (written and verbal)
Strong analytical and problem-solving skills with a data-driven approach to decision-making
Strong understanding of medical device design, manufacturing processes, and associated quality challenges
Preferred
Master's degree preferred
ASQ certifications such as Certified Quality Engineer (CQE), Certified Quality Manager (CQM/OE), or Six Sigma Black Belt
Benefits
A valuable, competitive package of compensation and benefits programs
Rewards and recognition opportunities that promote a performance-based culture
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