Complaint Specialist II

Becton Dickinson; Maryland; On-site; USD 76,000 - 121,000; Full time

Job summary

Becton, Dickinson and Company is seeking a Quality Complaint Coordinator to coordinate and supervise the handling of customer product complaints. You will review and process complaint records, ensure documentation compliance, and support audits and continuous improvement initiatives.

The role requires strong data analysis skills, familiarity with regulatory standards, and collaboration across multiple teams to resolve issues and ensure correct CAPA documentation.

Qualifications

• Bachelor's Degree or higher with experience in quality/complaints
• Experience reviewing and processing customer product complaints
• Familiarity with regulatory requirements (FDA QSR, ISO 13485) and quality systems

Responsibilities

• Coordinate and supervise the implementation and monitoring of customer product complaints
• Review, process and manage complaint records daily, including investigation and resolution
• Prepare and analyze reports and data trends from multiple systems (complaint management, ERP, regulatory)
• Escalate issues to Quality Assurance leadership as appropriate
• Provide guidance to cross-functional teams to ensure compliance and CAPA documentation
• Support audits, regional meetings, and continuous improvement initiatives

Skills

Quality management

Complaint handling

Data analysis

Regulatory compliance

Cross-functional collaboration

Excel

BI reporting

Education

Bachelor's Degree in a relevant field

Associate's Degree with 8+ years experience

Tools

TrackWise

ERP systems

Job description

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 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." Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed. Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role. Salary Range Information $75,800.00 - $121,300.00 USD Annual We are the #MakersofPossible Working together, we make products that patients, families and their healthcare professionals rely on. We do this because we are committed to advancing the world of health. But it takes the imagination and passion of all of us at BD, from manufacturing to marketing, to look at the impossible and find solutions that turn dreams into possibilities with real-life health benefits for people today, tomorrow and beyond. We make this happen, together. We are the makers of possible. 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.