Senior Quality Engineer - Medical Device Compliance and Device Tracking

Senior Quality Engineer

Work Flexibility: Hybrid

What you will do -

• Maintains the global Device Tracking system records and ensures compliance with the FDA and other regulatory agencies device tracking requirements. Inside contacts are made at all levels on a regular basis with the US and the International Operations, Sales Support, Departmental In-House, and Service Support Teams. Regular contact with Customers/End Users and Distributors.
• Fast-paced environment requiring significant use of standard office equipment including computer keyboard, monitor, and mouse, and telephone.
• Enter and maintain current functional location in ERP System; generate assets as requested/required to support business functions and assist internal departments on troubleshooting device locations and may take on process ownership of device tracking system, including representing device tracking during internal and external audits.
• Liaise with Distributors to ensure timely receipt of tracing reports; conduct Distributors device inventory verification and support the Device Tracking System Audit activities.
• Coordinate with In-House departments to assure compliance with corporate device tracking process; guide organization in interpreting governmental regulations, agency guidelines and internal policies to assure compliance and ensure that policies and procedures implemented comply with appropriate regulations.
• Interface and coordinate with various System Owners in the development and improvement of system policy and procedures and provide leadership and support to Quality System projects.
• The execution of Executive Management Review process through the compilation of relevant Quality System metrics and reports and perform other related duties as assigned.

What you will need-

• Bachelor’s degree
• Experience- 5 years - 7 years ; 3+ years of experience in regulated industry, preferably Medical Device
• Experience handling large amounts of data where data integrity and accuracy is critical

Travel Percentage: 40%

Experience Level

Senior Level