Technical Program Manager I

Summary:

We are looking for someone who will you'll work closely with cross-functional teams to ensure team members are trained and understand how a Quality Management System impacts their different cross-functional deliverables.

Responsibilities:

• You will work closely with Software and Hardware Design Engineers, Electrical Engineers, Test Engineers, Module Engineers, Compliance, Contract Manufacturers, Program Managers, and Regulatory Affairs to produce high-quality products.
• You will be working with these cross-functional team members to investigate CAPAs, product complaints and implement process improvements.
• You'll need excellent communication skills, organization skills, and attention to detail in order to act as the point of contact for product investigations, quality, and progress updates.

Skills/ Education/ Experience:

• Bachelor's degree in Engineering or Science Related Field Experience with pharmaceutical, digital health, medical device or mobile medical applications.
• 1-3 years of experience in US ( 21 CFR Part 820) and International Medical Device Regulations, ISO13485:2016 or other medical device related standards.
• Strong knowledge of quality concepts - such as Failure Mode Effect Analysis (xFMEA), Root Cause Analysis, Nonconformances (NC) and Corrective and Preventive Actions (CAPA).
• Innovative and intensely committed to ensure that products we supply conform to FDA and Quality System Regulations (cGMPs).-Knowledge of root cause analysis methodology-
• Experience with product investigations and customer complaint management
• Proficient in MS Office programs (Word, Excel, PowerPoint), Google Suite
• Experience with PLM (or Document Control) or QMS tools such as: Agile, Arena, Documentum, TrackWise, Pilgrim, MasterControl, TeamCenter

Skills :