Job Description Summary

This role is responsible for Medication Management Solutions (MMS) Dispensing Designated Complaint Handling Unit (DCHU) complaint compliance activities. This role is responsible for the enhancement of processes, procedures and program management for MMS Infusion complaints. This position is accountable for ensuring that MMS Infusion complaints align with ISO, FDA, and other regional or country post-market regulations through the implementation of an efficient complaint review process resulting in effective corrections or corrective and preventive actions, where vital. This position is also accountable for all DCHU CAPA management and Additional Information Request (AIR) responsibilities.

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. 

Responsibilities

• Manage all post market quality aspects of the CAPA process: initiation, investigation, planning, implementation, verification of effectiveness and TrackWise administration.
• Provide clarification and guidance to teams on overall quality system with emphasis in process controls. 
• Report status of projects and CAPAs to designated functional leaders according to established frequencies.
• Work closely with project team members and other cross-functional teams to ensure CAPA and project deliverables are met.
• Coordinate with MMS complaint handling sites to ensure consistency in complaint records and implements solutions and process efficiencies, wherever possible.  
• Monitors and ensures compliance with company policies and international standards/regulations.
• Identifies areas requiring quality improvement, initiates and follows through on plans of action necessary for implementation.
• Ensure that CAPA and project files are completed on time and are auditable.
• Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross-functional teams.
• Draft or assist in drafting Quality Plans, SOPs, and SWIs pertaining to complaint handling.  
• Oversight of regulatory communication (i.e., responses to FDA requests and monitorization of applicable regulatory databases).
• Review and quality check of complaint files to ensure complaints conform to regulatory requirements and company policies and procedures.
• Identify any potential gaps that may lead to audit findings and work with complaint management for remediation of those gaps.
• Work on additional ad hoc projects, as assigned.

Qualifications

Education and Experience

• Bachelor’s degree, and a minimum of 3+ years with medical device complaint handling/post-market surveillance/medical device regulations or experience in a similar regulated environment.
• Experience in TrackWise, SAP, or Salesforce enterprise platforms is preferred.

Knowledge and Skills

• Solid understanding of QA, Regulatory, and Quality Compliance in the medical device industry. Knowledge of infusion pumps/infusion therapy preferred.
• TrackWise Complaint and/or CAPA systems proficiency.
• Have knowledge and understanding of the FDA 21 CFR 820, 803, ISO standards, IMDRF coding, EU MDR Vigilance, and other worldwide regulations as they apply to complaint handling and adverse event reporting.
• Ability to read, analyze, and interpret complaints and adverse events with the willingness and potential for understanding basic medical terminology.
• Excellent writing and summarization skills and knowledge of good documentation practices.
• Meticulous attention to detail and proven accuracy in record keeping practices
• Strong proficiency with MS Office tools (i.e., Word, Excel, PowerPoint, Outlook).
• Completes work assignments both independently with minimal supervision/guidance and collaboratively.
• Ability to coordinate and prioritize assignments and optimally.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s 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 BD’s 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. 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.  

To learn more about BD visit https://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. 

Required Skills

Optional Skills

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Primary Work Location

USA CA - San Diego TC Bldg C&D

Additional Locations

Work Shift

US BD 1st Shift 830am-4pm (United States of America)

At BD, we are strongly committed to investing in our associates—their 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 or hourly rate 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 or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information

102 000,00 $ - 168 200,00 $ USD Annual