Product Quality Analyst

Primary Job Function: Responsible for data analysis related to AMO post-market product complaints and reporting on trends to ensure compliance to all applicable Corporate and Divisional policies and procedures. Demonstrates thorough understanding of Good Manufacturing Practices (GMPs), FDA Code of Federal Regulations (CFRs) and ISO13485. Actively participates in departmental process improvements and effectively communicates knowledge to contribute to overall success of AMO.

Core Job Responsibilities: Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Provide Quality Assurance leadership with product quality data and complaint trending to drive product improvements and Corrective and Preventive Actions. Prepare or assist department leadership with monthly trending reports, annual post-market surveillance reports and other monthly and quarterly reports. Participate in various process improvement projects. Responsibilities include developing and reporting on relevant complaint handling system metrics.

Works autonomously to identify areas for inquiry. Recognizes that failure to achieve results or erroneous

decisions or recommendations may result in significant non-compliance issues. Analyze and report on complaint process metrics.

The position is accountable for:

- timely and accurate product complaint data analysis and reporting.

- developing new and improving existing data analysis tools while maintaining compliance to all regulations.

Minimum Education, Experience and Training Required: Bachelor's degree in a sciences or engineering discipline or similar field or an equivalent combination of education plus work experience. 1+ years of experience in data analysis, preferably in a regulated medical products manufacturer

- Knowledge of and experience using SQL to construct queries

- Knowledge of and experience using MS Excel to analyze data

- Good verbal and written communication skills

- Ability to work well in a team environment.