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.

Requirements:

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

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).

Key Traits for Success:

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