PTS Advance is looking to speak with Quality professionals to join our client, a medical device manufacturer, in the Fort Lauderdale, FL area as a QA Device Development Engineer.

In this role, you will work to develop and execute activities related to quality in the design and development of programs for my clients' facilities in the US. You will do so by providing the assistance required to meet overall quality objectives in all phases of product development in compliance with operating procedures.

Main Responsibilities

• Support internal and external customers with QA representation to navigate the Design Control and Risk Management processes throughout program lifecycles.
• Generation and maintenance of Risk Management files associated with assigned device development programs
• Authors the RMP, HIC, REE, PRA Matrix, and RMR.
• Collaborates / supports the Development team in the generation of the Design FMEA / PRA Matrix. Ensures End User Severity is incorporated into the PRA Matrix.
• Upon completion of Design Assessment and Design Verification ensures review and revision of the Design FMEA and REE / PRA Matrix are made to reflect design iterations.
• Summarizes the Process FMEA and Equipment FMEA, as appropriate, in the PRA Matrix.
• Fulfills the role of QA Leader during the execution of the Design Control Planning Phase and Design Phase.
• Shares QA Leader role with QA TW during the execution of the Design Control Engineering Phase and Validation Phase.
• Generation and maintenance of Risk Management files

Skills and Qualifications

• Bachelor's degree
• Excellent communication skills
• Strong in Word, Excel, PowerPoint, etc.

If you or someone you know may be interested, please send your resume to Lisa.Oster@PTSadvance.com or visit us at jobs.PTSadvance.com to learn more about the role. #LifeSciences #PTSAdvancejobs #PTSAdvance