- Manage Local Calibration Program for ISO 13485 medical device manufacturer. Manage all aspects of the calibration of measurement and control devices. Maintain accurate records of all services performed in compliance with company defined QMS and industry regulations. Maintain internal calibration procedures for all equipment including updating procedures as needed to reflect industry best practices. Develop and author work instructions or procedures needed to perform calibrations of any new equipment added to program. Ensure these procedures reflect industry best practices and comply with internal and industry standards. Ensure equipment and device accuracy is adequate for its intended use and ensure these devices can maintain their accuracy throughout the devices life cycle. Ensure all services are completed on time and are in compliance with internal and industry standards. Effectively communicate equipment issue's to appropriate department leads to ensure minimum downtime due to faulty equipment. Analyze the risk to any product if equipment is found out of tolerance and accurately document the affect the out of tolerance condition may have had on product. Effectively communicate calibration requirements to outside calibration vendors. - Manage team of local Complaint Coordinators for global Complaint Management Program in accordance to ISO 13485 regulations. Investigate, analyze and report defects in product returns from customers. Perform failure mode analysis, root cause analysis and develop corrective actions accordingly. Analyze complaint data using trending and metrics to monitor and communicate defects to manufacturing group. Ensure closure of complaints meets ISO 13485 medical device standards. Provide post market data to engineering and manufacturing leads through periodic complaint review board meetings. Effectively communicate any adverse trends or emerging issues to manufacturing leads. Ensure timely response to customers.

Lead team of 12-15 warehouse workers