BD · 7 hours ago
Sr. Design Quality Systems Manager
San Diego, CA
Full-time
Onsite
Senior Level, Lead/Staff
$158K/yr - $261K/yr
10+ years expBD is one of the largest global medical technology companies in the world, focused on advancing health through innovative solutions. The Sr. Design Quality Systems Manager is responsible for ensuring compliance of the Design Center Quality System in San Diego, applying design control requirements, and leading a team to maintain quality standards.
Health CareMedical DeviceTechnical Support
Responsibilities
Maintain and improve the IPD San Diego Design Center Quality System, provide strategic direction so that the QS architecture support the business needs and future growth
Establish and maintain QMS linkages with all entities that interact with the IPD San Diego Design Center. Maintains quality agreements
Monitor the effectiveness of the QMS, review key indicators, address negative trends, and prepare Management Review meetings
Maintain effectiveness of the CAPA process
Ensure compliance of the San Diego Design Center QMS, maintain effectiveness of the internal audit program, coordinate external audits and ensure that Design center sites are ready to manage external audits
Ensure effective and consistent application of design controls across all programs in scope of San Diego Design Center; Participate in Design Review meetings and establish and maintain a Design Controls training program
Collaborates with core teams to establish Design Controls and Risk Management implementation strategies in compliance with internal, Industry, and Government Standards
Responsible for Risk Management system. Ensures consistent application of risk management, its effectiveness, and for maintaining compliance with internal, Industry, and Government Standards
Responsible for establishing and maintaining linkages between Risk Management and other processes such as Post Market Quality, Design Control, and Change Control
Provide Quality functional support for labeling programs and labeling process improvement activities
Implement, Measure and Report on the progress of the Quality Management Strategic initiatives, such as Inspire Quality
Software validation
Quality functional support for implementation of electronic systems that that impact the QMS
Leads a team of specialist that support the Quality Management System, including the CAPA and internal audit processes
Assignments are often self-initiated. Determine and pursue course of action necessary to obtain desired results
Participates in, and may provide leadership for multi-disciplinary projects
Considered Site Quality Management System Subject Matter Expert, including Design Controls and Risk Management
Qualification
Required
Bachelor's Degree required in engineering or life sciences related field
Minimum ten (10) years progressive experience in Quality Assurance within an FDA regulated industry; QA administration and planning experience required
Minimum 3 (three) years of direct management experience of QA professional and technical staff
Expertise in regulations affecting medical devices marketed in all regions throughout the world
Expertise in failure investigation and medical device CAPA process
Experience in medical device product development and application of Design Controls
Strong understanding of design quality assurance
Lead Quality System auditor experience
Experience managing regulatory audits and responding to regulatory authorities
Proven leadership capability and teamwork across functions and regions
Ability to manage complex situations and make sound decisions
Preferred
Certified as Engineer or Auditor by the American Society for Quality (ASQ)
Green Belt or Black Belt from a recognized program
Experience working in a design center
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
Maureen Mazurek
Chief Sustainability and EHS Officer
Recent News
2026-01-22
Bizjournals.com Feed (2025-11-12 15:43:17)
2026-01-20
Medical Device Network
2026-01-17
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