Manager, Quality Engineering

Johnson & Johnson

Alajuela, Costa Rica
Not specified (assumed to be onsite due to the nature of the role and industry).
Sustaining quality engineering
Complaint investigation programs
Fda, iso 13485 compliance
Johnson & Johnson is seeking a Manager of Quality Engineering in Alajuela, Costa Rica, to lead the Sustaining Quality Engineering and Complaint Investigation programs at Shockwave Medical. The ideal candidate will have a strong background in the medical device industry, including supervisory experience, and will be responsible for ensuring compliance with quality management systems while driving continuous improvement initiatives

Job Summary

  • This role provides leadership for the Sustaining Quality Engineering and Complaint Investigation programs, supporting both manufacturing operations and customer complaints.
  • Develops and implements procedures and systems to assure compliance with FDA, ISO 13485, and other applicable regulatory standards for medical devices.
  • Responsible for coaching, training, and development of subordinates, and driving assigned CAPAs to successful completion.

Matching Summary

Match Score: 85

Johnson & Johnson is seeking a Manager of Quality Engineering in Alajuela, Costa Rica, to lead the Sustaining Quality Engineering and Complaint Investigation programs at Shockwave Medical. The ideal candidate will have a strong background in the medical device industry, including supervisory experience, and will be responsible for ensuring compliance with quality management systems while driving continuous improvement initiatives.

Skills & Requirements

Must-have

  • Sustaining Quality Engineering
  • Complaint Investigation programs
  • FDA, ISO 13485 compliance
  • Quality System activities management
  • CAPA completion
  • audit readiness

Nice-to-have

  • Coaching and development
  • Inclusive Leadership
  • Fact-Based Decision Making
  • Lean Supply Chain Management

Key Requirements

  • Bachelor’s Degree in an engineering discipline
  • Minimum of seven (7) years of experience in medical device industry
  • Minimum of 2 years of experience in supervisory or management positions
  • Strong front room audit experience
  • Experience investigating customer complaints
  • Experience with software validation is preferred
  • May be required to travel 20% of the time

Work Rights

Not specified

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