Joseph P.

Worked within the Product Development Late Phase and Transfer Team to support the Verification and Transfer activities for PMA and 501(k) FDA approved products. Skills developed include: • Quality Management System – Extensive understanding of working within a quality management system that conforms to the ISO13485 standards and the FDA 21 CFR §820. Including authoring critical SOPs for Goods Receipt and Process Validation. • Design Controls – Contributed to the Design History File for FDA PMA and 501(k) approved products, by authoring deviations including those classed as ‘serious’, and producing tables for the inclusion in reports. Author design Device Master Records. • Troubleshooting – Conducted detailed investigation and reporting to find root causes in equipment faults, followed by finding solutions that ensure timelines are not greatly affected. • Regulatory Affairs – Assisted closely in customer, TUV and FDA audits, giving me a good appreciation of an auditors thought process and the potential problems that can arise within a quality system.