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Post Market Surveillance Specialist
at ExacTech, inc.
Duties and Responsibilities (Key Deliverables):
- Coordinate and track issues that are escalated for consideration for Filed Corrective Action, CAPA and other potential actions per Exactech procedures, including, but not limited to:
- Plan, conduct, and document Correction and Removal Committee meetings
- Track, communicate and follow up with team members to complete all action items in a timely manner
- Track and drive committee to decisions in a timely manner
- Analyze post market surveillance data as requested by internal business partners.
- Providing training to employees, sales agents/representatives regarding the internal requirements for issue escalation.
- Assist the Sr. QA Manager, Post Market Surveillance with analysis and interpretation of complaint data for regulatory submissions, regulatory agency requests, monthly trending and/or management review.
- Prepares ad hoc report summaries as needed.
- Performs complaint trend analyses and product risk assessments as applicable.
- Communicates complaint data and relevant clinical information to internal customers in quality, risk management, manufacturing and new product development in support of complaint investigations.
- Represents the complaint team and provides support for cross functional teams, i.e. CAPA, Risk Management, Escalation, etc.
- Draft responses to Regulatory Agencies who inquire about complaint related issues.
- Knowing and applying Exactech’s Quality System and any appropriate federal and international standards.
- Assisting and supporting other employees, teams, and sales personnel as necessary.
- Practicing Exactech’s Values.
Associate's Degree from an accredited institution required; Bachelor's Degree preferred.
Functional/Technical Knowledge, Skills and Abilities Required: