Quality Lead

Programmers.io; Reedsville (PA); On-site; USD 90,000 - 140,000; Full time

Job summary

Programmers.io is seeking a quality engineering professional to support remediation and regulatory compliance initiatives in the medical device sector. You will manage CAPA, nonconformance, deviation, complaint handling, and quality system activities.

You will conduct root cause analyses, drive quality improvements, review metrics, and assist FDA readiness programs. The role requires experience with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and design controls.

Qualifications

• Experience in CAPA, nonconformance, and deviation management.
• Strong root cause analysis skills (5 Why, Fishbone, FTA).
• Experience with quality metrics and trend analysis.
• Familiarity with FDA 21 CFR Part 820, ISO 13485, ISO 14971.
• Experience supporting design controls and validation.

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.

Skills

CAPA, Nonconformance, Deviation Mgmt

Root Cause Analysis

Quality Metrics & Trend Analysis

FDA 21 CFR Part 820

Design Controls & Validation Support

Education

Bachelor's degree in Engineering

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.
• 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.
• 8+ years of Medical Device Quality experience.
• Experience with Class II/III medical devices.
• Experience supporting FDA, MDSAP, and ISO audits