BD · 10 hours ago
Program Manager – MMS Projects & CAPA
USA CA - San Diego TC Bldg C&D
Full-time
Onsite
Mid, Senior Level
$125K/yr - $206K/yr
5+ years expBD is one of the largest global medical technology companies in the world, seeking a dynamic Program Manager to drive strategic projects focused on CAPA process transformation. The role involves overseeing the BD Quality CAPA portfolio, ensuring compliance with FDA regulations and ISO standards, and leading cross-functional teams to improve quality and operational efficiency.
Health CareMedical DeviceTechnical Support
Responsibilities
Lead and drive strategic quality and operational improvement initiatives across the organization, ensuring alignment with business objectives and regulatory requirements
Develop project plans, timelines, and resource allocation strategies to ensure successful delivery of cross-functional programs and initiatives
Facilitate stakeholder engagement and communication across all levels of the organization to drive program success and organizational change
Monitor program progress, identify risks and dependencies, and implement mitigation strategies to keep initiatives on track
Provide continuous and rigorous assessment of CAPA activities and documentation to assure compliance with BD internal policies in general and specific to CAPA process, FDA regulations, ISO 13485, Medical Device Requirements, and governmental regulations through the review of CAPA records at critical phases
Lead the development and implementation of CAPA processes within the R&D department
Ensure compliance with FDA regulations, ISO standards, and other applicable quality standards
Facilitate cross-functional teams to identify root causes of issues and develop effective corrective and preventive actions
Monitor CAPA activities for timely execution and effectiveness of implemented actions
Prepare and present CAPA reports and metrics to senior management
Conduct training sessions for R&D staff on CAPA processes and best practices
Collaborate with Quality Assurance and Regulatory Affairs teams to maintain consistent quality standards
Act as a point of contact for CAPA-related inquiries and provide guidance to team members
Support continuous improvement initiatives by utilizing CAPA insights to enhance product development processes
Devises and implements methods and procedures for inspecting, testing, and evaluating the effectiveness and accuracy of corrective actions ensuring no impact to products, processes or patient safety
Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with regulatory requirements
May support CAPA in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality
May participate in CAPA review board activity and support audits
Qualification
Required
Bachelor's degree in Engineering or Science degree with a minimum of 5 years of project management experience within the medical device industry, with expertise in CAPA and Quality Systems preferred
Preferred
Experience in medical device, pharmaceutical and/or a comparable regulated environment
Experience conducting effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques
Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques
Support CAPA process and several individual records for a specific set of CAPAs that will have high visibility and require increased oversight
Experience working with non-conformances, corrective and preventive actions
Strong analytical, process improvement, critical thinking, and decision-making skills
Ability to educate people in the CAPA program
CAPA documentation systems experience (e.g. Trackwise)
Influence management skills: ability to work constructively across all functions of the organization as well as external customers
Project management skills
PMP, lean and six sigma green or black belt
Experience reviewing technical documentation
Strong written and verbal communication skills
Understanding of FDA regulations (21 CFR 820, 210/211 as applicable and Part 11), ISO 13485, and other applicable quality standards
Experience with internal and external audits
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 Interventional Segment
Recent News
2026-02-09
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