BD (Becton, Dickinson and Company) Complaint Compliance Specialist (Specialist 3) in San Diego, California
Job Description Summary
The Complaint Compliance Specialist (Specialist 3) position is responsible for Medication Management Solutions (MMS) Infusion Designated Complaint Handling Unit (DCHU) complaint compliance activities. This role is responsible for the the review of complaint records, processes, and procedures for MMS Infusion complaints. This position is accountable for ensuring that MMS Infusion complaints comply 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 necessary.
Duties & Responsibilities
Conducts review processes crafted to ensure complaints conform to regulatory requirements and company policies and procedures
Coordinates with MMS complaint handling sites to ensure consistency in complaint records and implements solutions and process efficiencies wherever possible
Ensures appropriate correction and/or corrective action is initiated when applicable. Initiates, owns, or assists with internal audit and CAPA actions as they relate to complaint records and/or adverse event reporting
Participates in complaint record remediation planning and execution when vital
Partners with other quality professionals to address complaint related issues identified throughout the organization
Demonstrates positive principles of the BD WAY, such as: 1) Values: Our standards of behavior, 2) Leadership commitments: How we lead ourselves and our work, and 3) Approach: The demeanor we bring to our work
May coordinate activities with others and/or perform other related duties and responsibilities, as assigned, in relationship to complaint handling and adverse event reporting
Accountable for individual results and impact on teams.
Shares experience and lessons learned with others to improve processes and procedures
Acts as a technical specialist within complaint handling and adverse event reporting to mentor or train new associates to complaint handling, as the need arises
Reports status of assignments to his/her supervisor on a routine basis, and follows through to complete assignments through corrections of complaint records, and completion of CAPAs or audit actions
Align with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
May perform other complaint handling/adverse event reporting related duties and responsibilities as assigned
Knowledge and Skills
Desire for the repetitive auditing and reviewing of samples of complaint records sharing ownership of corrective actions with complaint handling teams
Experience and willingness to work within BD’s TrackWise Complaint Handling and CAPA systems
Develops competence and expertise in his/her area by performing routine work with suggestions on process improvements
Ability to organize and prioritize assignments and optimally manages multiple tasks as assigned
Knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR
820, 803 and International Organization for Standardization (ISO), Canadian Mandatory Reporting, International Medical Device Regulators Forum (IMDRF) coding, EU MDR Vigilance, and other worldwide regulations as they apply to complaint handling and adverse event reporting
Excellent writing skills, summarization skills, and knowledgeable of Quality’s good documentation practices for compliant record corrections
Meticulous attention to detail and proven accuracy in record keeping practices
Strong proficiency with MS Office tools to include Word, Excel, PowerPoint and Outlook, TrackWise Complaint handling and/or CAPA Systems
Completes work assignments independently on his/her own with minimal supervision/guidance
Education & Experience
Demonstrated ability with medical device complaint handling / post-market surveillance / medical device regulations or experience in a similar regulated environment
Working knowledge of QA, Regulatory, Quality Compliance in a medical device industry
Knowledge of infusion pumps / infusion therapy preferred
TrackWise Complaint and/or CAPA systems proficiency
Ability to read, analyze, and interpret complaints, and adverse events with the willingness and potential for understanding basic medical terminology
This position can be located out of any BD location in the United States.
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!
Primary Work Location
USA CA - San Diego TC Bldg C&D
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.