Complaint Specialist II

BD; Cockeysville (MD); On-site; USD 76,000 - 121,000; Full time

Job summary

BD is seeking a Quality Complaints Coordinator to oversee the handling and documentation of customer product complaints in a regulated medical device environment. You will coordinate investigations, ensure adherence to Quality System regulations, and support cross-functional teams to drive timely resolutions.

With a focus on on-site collaboration at our USA MD Sparks location, you will leverage Trackwise and BI reporting tools to analyze trends, maintain compliant records, and contribute to CAPA

Qualifications

• Regulatory knowledge for medical devices (FDA QSR, ISO 13485, EU MDR/IVDR)
• Experience applying quality systems to medical device manufacturing.
• Advanced Excel and BI reporting skills.

Responsibilities

• Coordinate and supervise customer product complaint handling and documentation.
• Ensure compliance with Quality System regulations and procedures.
• Investigate, process, and resolve customer complaints daily.
• Maintain accurate complaint records across systems.
• Support CAPA documentation and root cause investigations.

Skills

Data analysis

Excel

BI Reporting

Quality Systems

Education

Bachelor’s Degree

Associate's Degree

Tools

Trackwise

SA

Job description

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.

Job Description

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.

Required Qualifications

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

Preferred Qualifications

• 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.

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?

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.

Primary Work Location

USA MD - Sparks - 7 Loveton Circle

Additional Locations

USA CA - Milpitas 135

Work Shift

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Salary Range Information

$75,800.00 - $121,300.00 USD Annual