Quality Engineer

Job Description

We are looking for an experienced CAPA Quality Engineer to drive CAPA initiatives, support project management activities, and communicate effectively across teams. The ideal candidate brings a minimum of five years of relevant experience and can quickly add value from day one.

Responsibilities

• Heavy focus on CAPA (Corrective & Preventive Action) execution.
• Own CAPA records from investigation through closure.
• Perform root cause analysis, issue assessment, and quality problem-solving.
• Manage a portfolio of CAPAs end-to-end.
• Partner with CAPA owners / cross-functional teams.
• Conduct investigations drive closure activities.
• Review data sources and ensure thorough documentation/compliance.
  
  

Must-Have Skillset

• Strong CAPA background (non-negotiable).
• ISO 13485 experience (medical device/regulatory environment).
• Technical/STEM background.
• Proven communication skills (highly emphasized due to fast-paced environment).
• Ability to work independently and hit the ground running .
  
  

Nice-to-Have

• Project management experience (tracking, prioritization, coordination).
  
  

Traits For Success

• Strong communication stakeholder management (critical).
• Ability to handle multiple CAPAs simultaneously.
• Detail-oriented with strong quality systems mindset.
  
  

Qualifications

Must have Engineering degree- Technical experience and STEM related background.