Senior Quality Engineer

We are seeking a SrQuality Engineer with 5–8 years of experience in an ISO 13485 / FDA-regulated catheter shaft medical device manufacturing environment. This individual will thrive in a fast-paced setting, manage multiple projects simultaneously, and serve as the primary Quality support for the NPD Engineering team on site.

A CDMO background and catheter shaft manufacturing experience are strongly preferred, though strong medical device experience with extrusion or Class II/III devices will also be considered.

• Lead and execute process validation activities, including:
• IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification)
• TMV and related qualification protocols
• Support and maintain compliance with the Quality Management System (QMS), ensuring adherence to ISO 13485 and FDA regulations (21 CFR Part 820)
• CAPA investigations
• Non-conformance management
• Root cause analysis (RCA)
• Internal and external audits
• Provide Quality support for New Product Development (NPD) initiatives
• Participate in customer meetings and act as a direct Quality interface for customers
• Collaborate cross-functionally with Engineering, Operations, and Manufacturing teams
• Support equipment and process qualification, metrology activities, and automation initiatives

• 5–8 years of experience in ISO/FDA-regulated medical device manufacturing (catheter shaft environment preferred)
• Bachelor’s Degree in Engineering, Sciences, Manufacturing, or equivalent related experience in manufacturing or quality control
• Experience with Class II or Class III medical device contract manufacturing preferred
• Extrusion manufacturing experience strongly preferred
• Equipment and process qualification
• Auditing
• Strong communication skills with a confident, customer-facing presence
• Team-oriented mindset with the ability to work cross-functionally
• Proficiency in relevant business and quality software tools