Eder A. Villegas

Responsible to ensure that products released at the different production stages meet all predetermined requirements, and production activities are performed in regulatory compliance per FDA 21 CFR part 820 and ISO 13485 2016. Coordinates and executes activities required to achieve the quality performance metrics and guarantee the continuous effectiveness of the QMS.

• Follow up with owners of CAPAs, NCMRs, Customer Complaints to ensure these are addressed on a timely manner.
• Leads and develops quality improvement projects to reduce nonconformances reported in NCMR and customer complaints.
• -Execute internal audits and provide support on external audits.
• Develops, modifies and maintains updated the quality system documentation.
• Monitoring underling performance and recommend training plans.
• Provide support in the introduction and transfer of new products and for processes validation
• Leader of investigation of customer complaints and coordinates with other departments the implementation of corrective actions.
• Collects, analyzes and present quality performance metrics for daily meetings and management review meetings.

• Developed inspection plans based on design specifications, ensuring all critical dimensions and performance criteria were verified throughout the manufacturing process.
• Improved customer satisfaction levels with timely resolution of non-conformance issues and effective corrective actions.
• Performed quality inspections and drafted reports to detail non-conforming material issues.
• Contributed to root cause analysis to determine core reason for failures and errors.
• Responsible for regulatory compliance of NADCAP certified special processes.
• Responsible for understanding and interpretation of customer specifications such as standards, drawings, or internal customer procedures.