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).
- bility 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).
- bility to handle multiple CAPAs simultaneously.
- Detail-oriented with strong quality systems mindset.
Qualifications: Must have Engineering degree- Technical experience and STEM related background.
