Devin R. Email & Phone Number

Indianapolis, Indiana Area

- Work to improve the processes involved with addressing customer support and product quality analysis.- Draft and drive processes/planning for post-launch surveillance.- Work with 3rd party groups to ensure proper lineation of expected role based on SLAs.- Monitor trending data to provide information for NC and CAPA processes.

Indianapolis, Indiana Area

• Continued in effort to draft testing procedures for medical devices with the aid of SOPs, CAPA, and FMEA practices.
• Project member working to reconcile root cause code identification changes between separate company locations due to regulatory pressure.
• Worked as member of team to support in data analysis for PQM review.
• Worked as member of team to reconcile root cause code assignment with updated regulatory compliance requirements.

Indianapolis, Indiana Area

• Worked as team member in ensuring that medical device malfunctions were correctly reported and documented by FDA and internal standards to prepare for device testing.
• Worked in ensuring that proper testing was performed on returned devices with alleged malfunctions and documented for FMEA and CAPA purposes.
• Drafted testing procedures for medical devices with the aid of SOPs, CAPA, and FMEA practices.

Indianapolis, Indiana Area

Worked to lead a team of standardized test scorers. Advised in proper scoring protocol and lead training for each member of the team. Ensured consistent scoring techniques through the use of performance data analysis.

Master’S Degree, Orthopedics & Biomechanics

Bachelor'S Of Science, Biomedical Engineering

Activities and Societies: Tau Beta Pi Engineering Honor Society Order of the Engineer