Remotely
risk managementsupplier qualityquality management systemcapafda qsrarenaiso 13485
Job Description
📋 Description
- Support Quality Management System across product development, manufacturing, supplier operations
- Investigate issues and drive effective, compliant solutions with cross-functional teams.
- Contribute to CAPA, audits, supplier quality, change management, and regulatory readiness.
- Collaborate with Engineering, Operations, Regulatory Affairs, and external suppliers to improve
🎯 Requirements
- Bachelor’s degree in Engineering, Quality, Life Sciences, or related technical discipline
- 5–8 years in Quality Engineering/QA/Quality Systems in medical device industry
- Knowledge of FDA QSR, ISO 13485, risk management principles, and medical device quality requirements
- Experience with investigations, CAPA, supplier quality, and change management
- Cross-functional collaboration across Engineering, Manufacturing, Operations, Regulatory Affairs
- Strong problem-solving, analytical, organizational, and communication skills
🎁 Benefits
- Base salary $95,000–$105,000 annually
- Comprehensive benefits package beginning Day 1
- Medical, dental, and vision insurance
- Life insurance coverage
- 401(k) plan with employer matching
- Contribution to quality, compliance, innovation, and continuous improvement in a medical device
