Job Summary

• The Manager, Quality provides leadership for the Sustaining Quality Engineering and Complaint Investigation programs at Shockwave Medical, supporting both manufacturing operations and customer complaints.
• This role develops and implements procedures and systems to assure Shockwave Medical complies with FDA, ISO 13485, and other applicable regulatory standards related to the medical device industry.
• Responsibilities include managing direct reports, ensuring QMS compliance, partnering with manufacturing for solutions, and driving CAPAs to completion.

Matching Summary

Skills & Requirements

Key Requirements

• Bachelor’s Degree in engineering
• 7 years medical device industry experience
• 2 years supervisory/management experience
• Software validation experience preferred
• Willing to work in cleanroom
• 20% travel required

Work Rights