Quality Engineer - Medical Device, CAPA & Process Excellence

JobDiva, Inc.; Cambridge (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

JobDiva, Inc. in Cambridge, MA seeks a Quality & Regulatory Specialist to monitor manufacturing quality and ensure compliance with FDA 21 CFR Part 820, ISO 13485, and GMP. You will manage CAPA, conduct root cause analyses, and support audits with cross-functional teams.

The role includes maintaining QMS documentation (SOPs, DHF, DMR, DHR), driving continuous improvement with Lean Six Sigma, and ensuring traceability of records across production and quality systems.

Qualifications

• Bachelor's degree in engineering or related field.
• Experience in medical device manufacturing preferred.
• Strong understanding of regulatory and quality systems.
• Good communication and cross-functional collaboration skills.
• Manufacturing Quality.
• GMP.
• ISO 13485.
• FDA 21 CFR Part 820.
• CAPA.
• Root Cause Analysis (RCA).
• Risk Management (FMEA).
• Statistical Process Control (SPC).
• Audit Compliance.
• Quality Management System (QMS).
• Continuous Improvement.

Responsibilities

• Monitor manufacturing processes to ensure product quality and compliance with defined standards.
• Manage non-conformances (Client), deviations, and CAPA activities.
• Perform root cause analysis (RCA) and implement corrective and preventive actions.
• Support internal and external audits (FDA, ISO).
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and GMP requirements.
• Maintain and update Quality Management System (QMS) documentation including SOPs, DHF, DMR, and DHR.
• Collaborate with manufacturing, engineering, and supplier teams to resolve quality issues.
• Drive continuous improvement initiatives using Lean Six Sigma methodologies.
• Perform process monitoring and support validation activities (IQ/OQ/PQ as required).
• Ensure proper documentation and traceability of manufacturing and quality records.

Skills

CAPA management

Root cause analysis

Regulatory compliance

Quality systems

Lean Six Sigma

Cross-functional collaboration

Process monitoring

Documentation control

Audit support

FDA 21 CFR Part 820

Education

Bachelor's degree in engineering or related field

Tools

QMS software

Job description

JobDiva, Inc. in Cambridge, MA seeks a Quality & Regulatory Specialist to monitor manufacturing quality and ensure compliance with FDA 21 CFR Part 820, ISO 13485, and GMP. You will manage CAPA, conduct root cause analyses, and support audits with cross-functional teams.

The role includes maintaining QMS documentation (SOPs, DHF, DMR, DHR), driving continuous improvement with Lean Six Sigma, and ensuring traceability of records across production and quality systems.