Complaint Specialist II

Becton Dickinson Medical Devices•Sparks, NV

1d•Onsite

About The Position

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide. We are the people who give possibilities purpose 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. 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.

Requirements

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

Nice To Haves

Experience with Trackwise and SA

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.