Regulatory QA Coordinator: Medical Device Complaints & Compliance

Stryker; Washington (District of Columbia); On-site; USD 34,000 - 46,000; Full time

Job summary

Stryker is seeking a detail-oriented member to support the Emergency Care unit by reviewing service reports, identifying product complaints, and ensuring accurate documentation for regulatory and quality compliance.

The role involves coordinating with field service teams, gathering information, managing product returns, and maintaining complaint tracking systems to support audits and compliance processes.

Qualifications

• High school diploma or equivalent.
• 2+ years of professional experience.
• Proficiency with Microsoft Office applications.
• Associate or bachelor's degree (preferred).
• Experience with Track Wise or SalesForce/ServiceMax (preferred).
• Knowledge of medical device industry (preferred).

Responsibilities

• Review field service reports to determine if investigation or complaint reporting is needed.
• Enter, assign, and code complaints for tracking and trending analysis.
• Partner with Field Service to gather missing information and conduct screening.
• Coordinate product returns associated with complaints or investigations.
• Assist with internal audits and provide supporting documentation.

Education

Associate or Bachelor's degree (preferred)

Tools

TrackWise

SalesForce/ServiceMax

Job description

Stryker is seeking a detail-oriented member to support the Emergency Care unit by reviewing service reports, identifying product complaints, and ensuring accurate documentation for regulatory and quality compliance.

The role involves coordinating with field service teams, gathering information, managing product returns, and maintaining complaint tracking systems to support audits and compliance processes.