Quality Complaints Specialist II

RXinsider LTD.

Sparks Corner (MD)

On-site

USD 90,000 - 120,000

Full time

7 days ago
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Job summary

Becton, Dickinson and Company is seeking a Quality Complaint Manager in Maryland to coordinate and oversee customer product complaints. You will ensure documentation compliance, review investigations, and support CAPA activities in a regulated, high-volume environment.

Ideal candidates have regulatory knowledge, data analysis skills, and experience with quality systems for medical devices, with on-site collaboration and cross-functional teamwork across multiple systems.

Qualifications

  • Knowledge of US and international regulations and standards in medical devices.
  • Experience applying quality systems to medical device products.
  • Advanced data analysis using Excel and BI reporting.

Responsibilities

  • Coordinate and supervise customer product complaint processes.
  • Ensure documentation compliance with quality system procedures.
  • Review, investigate, and resolve customer complaints daily.
  • Maintain accurate complaint records and tracking.
  • Provide guidance to cross-functional teams on Quality System requirements.
  • Escalate regulatory concerns to Quality Assurance leadership.
  • Analyze data trends and prepare reports for stakeholders.
  • Collaborate across complaint management, ERP, and regulatory systems.
  • Support CAPA documentation and root-cause investigations.
  • Maintain awareness of applicable regulatory requirements.

Skills

Regulatory knowledge
Data analysis
Cross-functional collaboration

Education

Bachelor’s Degree in relevant field
Associate's Degree in relevant field

Tools

Trackwise
SA

Job description

Becton, Dickinson and Company is seeking a Quality Complaint Manager in Maryland to coordinate and oversee customer product complaints. You will ensure documentation compliance, review investigations, and support CAPA activities in a regulated, high-volume environment.

Ideal candidates have regulatory knowledge, data analysis skills, and experience with quality systems for medical devices, with on-site collaboration and cross-functional teamwork across multiple systems.

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