BD
Senior Technical Investigation Manager Hybrid
BD, San Diego, California, United States, 92189
Job Description
We are
the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a
maker of possible
with us.
We are seeking a highly skilled and experienced
Sr/Technical Investigation Manager
to join our dynamic team.
The Technical Investigation Manager will work with cross-functional teams within our MMS INF organization to drive consistent standard methodologies for the CAPA process, define metrics, and establish cross-functional oversight. Deploy CAPA processes and systems that improve compliance, efficiencies, and overall effectiveness. The Technical Investigation Manager is responsible for partnering with MMS Infusion leaders to develop processes and metrics that result in attaining MMS Infusion business improvement objectives and growth strategies.
The ideal candidate will have a strong background in technical problem-solving, extensive knowledge of Medical Device design controls and risk management, and exceptional project management capabilities. The role requires meticulous attention to detail, effective communication skills, and the ability to drive CAPA processes to ensure compliance and continuous improvement in a regulated environment.
The Technical Investigation Manager will be responsible for CAPA program management and oversight, including but not limited to initiation, coaching and training CAPA owners with investigation, root cause analysis, write-up, monitoring for verification and tracking, trending, and reporting of the CAPA program.
Key Responsibilities:
Establish and manage cross-functional CAPA program, including governance and oversight, to ensure compliance and consistency in areas of investigation, effectiveness, timeliness, quality, and thoroughness of content. Collaborate with cross-functional owners and stakeholders to ensure the program is compliant, executable, and meets user needs.
Provide leadership and influence among cross-functional departments and teams to ensure CAPA transformation initiatives are successfully executed.
Participate in process mapping with key senior leaders to ensure process and system requirements align.
Develop metrics for measuring program success.
Deploy CAPA coaching program to establish a gold standard for CAPA owners across MMS Infusion.
Lead and manage the CAPA process across MMS Infusion ensuring timely and effective progress of all CAPAs.
Utilize strong technical problem-solving skills to train cross-functional CAPA owners on how to define problems, conduct thorough root cause analysis, and implement robust CAPA solutions.
Apply deep knowledge of Medical Device design controls and risk management principles to assess CAPA impacts and ensure compliance with regulatory requirements (e.g., FDA, ISO).
Prepare and deliver clear, concise presentations to communicate CAPA strategies, progress, and outcomes.
Manage and oversee activities, including, but not limited to, the following:
CAPA initiation, closure, and investigation support of assigned CAPA owners.
CAPA review and approval, tracking, trending, and reporting on program.
Assisting in the communication with regulatory agencies, notified body, and competent authorities.
Required Skills and Qualifications:
Bachelor’s degree in engineering or related technical field; advanced degree preferred.
Minimum of 8 years of experience in the Medical Device industry with a focus on CAPA management, design controls, and risk management.
Proven experience in technical problem-solving, with a structured approach to root cause analysis.
Comprehensive understanding of regulatory requirements and standards applicable to Medical Devices (e.g., FDA QSR, ISO 13485).
Excellent project management skills, including the ability to prioritize tasks, manage timelines, and deliver results within budget.
Strong organizational skills and attention to detail, ensuring accuracy and completeness in CAPA documentation and records.
Outstanding communication skills, both verbal and written, with experience in effectively presenting technical information to diverse audiences, including during audits.
Preferred Qualifications:
Certification in Quality Management (e.g., ASQ Certified Quality Manager), or related disciplines.
Experience with CAPA software systems and tools.
Knowledge of Lean Six Sigma principles and methodologies.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
Primary Work Location
USA CA - San Diego TC Bldg C&D
Salary Range Information$155,200.00 - $256,000.00 USD Annual
#J-18808-Ljbffr
We are
the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a
maker of possible
with us.
We are seeking a highly skilled and experienced
Sr/Technical Investigation Manager
to join our dynamic team.
The Technical Investigation Manager will work with cross-functional teams within our MMS INF organization to drive consistent standard methodologies for the CAPA process, define metrics, and establish cross-functional oversight. Deploy CAPA processes and systems that improve compliance, efficiencies, and overall effectiveness. The Technical Investigation Manager is responsible for partnering with MMS Infusion leaders to develop processes and metrics that result in attaining MMS Infusion business improvement objectives and growth strategies.
The ideal candidate will have a strong background in technical problem-solving, extensive knowledge of Medical Device design controls and risk management, and exceptional project management capabilities. The role requires meticulous attention to detail, effective communication skills, and the ability to drive CAPA processes to ensure compliance and continuous improvement in a regulated environment.
The Technical Investigation Manager will be responsible for CAPA program management and oversight, including but not limited to initiation, coaching and training CAPA owners with investigation, root cause analysis, write-up, monitoring for verification and tracking, trending, and reporting of the CAPA program.
Key Responsibilities:
Establish and manage cross-functional CAPA program, including governance and oversight, to ensure compliance and consistency in areas of investigation, effectiveness, timeliness, quality, and thoroughness of content. Collaborate with cross-functional owners and stakeholders to ensure the program is compliant, executable, and meets user needs.
Provide leadership and influence among cross-functional departments and teams to ensure CAPA transformation initiatives are successfully executed.
Participate in process mapping with key senior leaders to ensure process and system requirements align.
Develop metrics for measuring program success.
Deploy CAPA coaching program to establish a gold standard for CAPA owners across MMS Infusion.
Lead and manage the CAPA process across MMS Infusion ensuring timely and effective progress of all CAPAs.
Utilize strong technical problem-solving skills to train cross-functional CAPA owners on how to define problems, conduct thorough root cause analysis, and implement robust CAPA solutions.
Apply deep knowledge of Medical Device design controls and risk management principles to assess CAPA impacts and ensure compliance with regulatory requirements (e.g., FDA, ISO).
Prepare and deliver clear, concise presentations to communicate CAPA strategies, progress, and outcomes.
Manage and oversee activities, including, but not limited to, the following:
CAPA initiation, closure, and investigation support of assigned CAPA owners.
CAPA review and approval, tracking, trending, and reporting on program.
Assisting in the communication with regulatory agencies, notified body, and competent authorities.
Required Skills and Qualifications:
Bachelor’s degree in engineering or related technical field; advanced degree preferred.
Minimum of 8 years of experience in the Medical Device industry with a focus on CAPA management, design controls, and risk management.
Proven experience in technical problem-solving, with a structured approach to root cause analysis.
Comprehensive understanding of regulatory requirements and standards applicable to Medical Devices (e.g., FDA QSR, ISO 13485).
Excellent project management skills, including the ability to prioritize tasks, manage timelines, and deliver results within budget.
Strong organizational skills and attention to detail, ensuring accuracy and completeness in CAPA documentation and records.
Outstanding communication skills, both verbal and written, with experience in effectively presenting technical information to diverse audiences, including during audits.
Preferred Qualifications:
Certification in Quality Management (e.g., ASQ Certified Quality Manager), or related disciplines.
Experience with CAPA software systems and tools.
Knowledge of Lean Six Sigma principles and methodologies.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
Primary Work Location
USA CA - San Diego TC Bldg C&D
Salary Range Information$155,200.00 - $256,000.00 USD Annual
#J-18808-Ljbffr