Complaint Compliance Specialist (Specialist 3)

Requirements

• Education & Experience
• Bachelor Degree
• Minimum of 3+ years of experience 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.
• Why join us?
• A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life's purpose through the work that they do every day.
• To learn more about BD visit https://jobs.bd.com/
• Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action

Benefits

Additional Information

Duties & Responsibilities Conducts review processes designed 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 necessary 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) Mindset: The attitude 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 required 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 Complies 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 effectively 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 demonstrated 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

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