Investigation Manager (Hybrid)
Job Description
Job Description SummaryJob DescriptionWe 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 its no small feat. It takes the imagination and passion of all of usfrom design and engineering to the manufacturing and marketing of our billions of MedTech products per yearto 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 youll 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 investigation manager to join our dynamic team.
The investigation manager will work with cross-functional teams within our MMS INF organization to drive consistent best practices for the CAPA process, define metrics, and establish cross-functional oversight. Deploy CAPA processes and systems that improve compliance, efficiencies, and overall effectiveness. The 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 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:
- Lead and manage the CAPA Initiation phase across MMS Infusion, ensuring timely and successful delivery of the problem statement and ownership alignment.
- Prepare and deliver clear, concise presentations to communicate CAPA metrics and trends.
- Owning activities including, but not limited to, the following:
- CAPA initiation, closure, and investigation support of assigned CAPA owners.
- CAPA Metric Analysis.
- Assisting in the communication with regulatory agencies, notified bodies, and competent authorities.
- Track-wise administration oversight across MMS Infusion.
Required Skills and Qualifications:
- Bachelors degree in engineering or related technical field; advanced degree preferred.
- Minimum of 5 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 ensure 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
For certain roles at BD, employment is contingent upon the Companys receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BDs Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
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. Its also a place where we help each other be great, we do whats 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, youll 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.
To learn more about BD visithttps://bd.com/careers
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
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Primary Work LocationUSA CA - San Diego TC Bldg C&DAdditional LocationsWork ShiftAt BD, we are strongly committed to investing in our associatestheir well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.
Salary ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary offered to a successful candidate is based on experience, education, skills, and actual work location. Salary ranges may vary for Field-based and Remote roles.
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