Complaint Specialist II

Reporting to the Quality Complaint Manager, this role is responsible for coordinating and supervising the implementation and monitoring of customer product complaints. This position is responsible for reviewing and processing the customer product complaint record, ensuring documentation compliance to established and formalized procedures. Responsibilities:
Perform moderately complex quality and complaint management activities while supporting audits, regional meetings, project teams, and continuous improvement initiatives. Ensure compliance with documentation requirements, complaint handling procedures, and Quality System regulations. Review, process, and manage customer product complaints on a daily basis, including investigation and resolution activities. Maintain accurate and compliant complaint records by identifying, correcting, and documenting discrepancies in quality records and tracking systems.

Contribute to project milestones and support the successful execution of quality-related initiatives. Provide guidance and support to associates and cross-functional teams to ensure adherence to Quality System Requirements. Verify and review the work of peers to promote accuracy, consistency, and compliance. Escalate quality concerns and issues to Quality Assurance leadership as appropriate. Work effectively across multiple systems, including complaint management, service, ERP, regulatory, and document management platforms.

Prepare and analyze reports, summaries, and data trends using both quantitative and qualitative information. Review and reconcile data across databases, spreadsheets, and reporting tools to ensure accuracy and completeness. Collaborate independently with cross-functional teams and departments to resolve issues and drive outcomes. Communicate effectively with stakeholders at various levels of the organization. Develop solutions for routine and moderately complex quality activities, including document changes, complaint file entries, CAPA documentation, and related tasks.

Participate in problem-solving efforts and support root cause investigation activities as needed. Maintain awareness of applicable regulatory and compliance requirements and ensure adherence to established policies and procedures. Participate in training related to regulatory requirements and quality system expectations. Proactively raise regulatory compliance questions or concerns to management. Follow all applicable BD procedures, policies, and training requirements as assigned.

Bachelor's Degree and 2 years of relevant experience or Associate's Degree and 8 years relevant experience

Experience with Trackwise and SA Knowledge and

Skills:

Knowledge of US and International regulations and standards that apply to the medical device industry, as it applies to Complaints, including FDA Quality Systems Regulations, ISO 13485, MDD, EU MDR/IVDR, Canadian MDR, Japan PMDA as well as ANVISA and TGA requirements. In-depth understanding of the application of quality systems to the medical device industry. Advanced proficiency in data analysis tools such as Excel and BI Reporting preferred.

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.

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