Quality Complaints Specialist II – Regulatory & Data

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

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