Full Job Description
About This Role:
About this role:
The QA Specialist - Post Market is a developing professional who independently manages routine to moderately complex complaints and applies regulatory knowledge within defined frameworks. Duties include, but are not limited to, day to day complaint review, investigation reports, adverse event reporting and complaints log and trend maintenance.
Responsibilities:
• Independently evaluate complaints to determine reportability in accordance with USA, European and Japan adverse event reporting requirements with guidance
• Perform and/or coordinate moderately complex complaint investigations in a timely manner
• Analyze technical information to support root cause assessment using established methods
• Collaborate cross-functionally to complete investigations
• Identify trends and/or issues for escalation
• Identify opportunities for and support process improvements
• Perform other quality and regulatory-related duties as assigned
Required Qualifications:
• Bachelor's Degree or Associate Degree in science, technology or medical fields
• 2 years of experience in Quality Assurance and / or a complaint processing role
• Working knowledge of applicable global medical device regulations particularly as they relate to complaint handling, vigilance, reporting timelines, and post-market surveillance
• Strong written and verbal communication skills
Location:
Remote - US
Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.
Estimated Pay Range
$74,000.00 - $93,000.00
