Christopher Wells Email & Phone Number

Mentor, Ohio, United States

Mentor, Ohio

Integral member of the QA/RA department that is responsible for the oversight and management of all quality control/quality assurance initiatives that support a manufacturing facility that produces steam sterilizers. Managed and processed Complaint records. Ran ongoing data analysis on the product and collaborated with other engineers to devise corrective solutions for any product deficiencies that are detected. Responsible for conducting Internal Audits for compliance to FDA 21CFR 820, ISO 13485, ISO 9001, and Health Canada Medical Device Regulations. Developed and ran IQ, OQ, and PQ scripts for software validation activities. Developed and implemented projects for use in the TrackWise system. Developed Crystal Reports for use in the TrackWise system. Gained a comprehensive understanding of FDA and Health Canada regulations and ISO standards.

Managed the shipping and receiving department for a product manufacturing facility. Responsible for planning, organizing, coordinating and scheduling the outgoing shipments and incoming delivery of materials. An unwavering attention to detail and the ability to apply my logistical and analytical skills were required qualifications. My ability to identify solutions that responded favorably to an environment that was tested daily by deadline sensitive shipping requirements and high pressure customer demands were critical to the overall operation.