Quality Lead

Job Description:

• Support quality remediation and compliance initiatives by managing nonconformance, CAPA, deviation, complaint handling, and quality system activities.
• Perform quality assessments, root cause investigations, data analysis, and quality improvement initiatives while ensuring compliance with medical device regulations and standards

Key Responsibilities:

• Manage CAPA, Nonconformance, and Deviation activities.
• Conduct Root Cause Analysis and corrective actions.
• Review quality metrics and identify recurring issues.
• Support quality audits and FDA readiness programs.
• Collaborate with cross-functional teams on quality improvements.

Required Skills:

• CAPA, Nonconformance, and Deviation Management.
• 10+ years of Medical Device Quality experience.
• Root Cause Analysis (5 Why, Fishbone, FTA).
• Quality Metrics and Trend Analysis.
• FDA 21 CFR Part 820, ISO 13485, ISO 14971.
• Design Controls and Validation Support

Preferred Qualifications:

• Bachelor’s degree in engineering discipline.
• Experience with Class II/III medical devices.
• Experience supporting FDA, MDSAP, and ISO audits