Quality Systems Specialist

Maintain Quality Records

• Maintain controlled documents and records, such as DHR/lot history, inspections, calibrations, training, audits, and complaints, per retention and traceability requirements.
• Support internal/external audits by preparing evidence, escorting auditors, and managing responses and follow-ups.
• Maintain approved supplier documentation; assist with incoming inspection issues and supplier change notifications.
• Log product complaints/feedback, route for evaluation, drive investigation actions, and maintain files through closure.

Facilitate Root Cause Analysis and Continuous Improvement

• Plan and conduct internal audits.
• Participate in CI projects to improve safety, quality, delivery, and cost; standardize best practices and help sustain gains.

Training and Documentation

• Create NCMR’s and track to completion.
• Issue training assignments on new/revised documents; track completion and escalate past due items.

Quality Metrics and Reporting

• Compile weekly/monthly KPIs and present to Quality leadership; support Management Review.

MRB Participation

• Maintain MRB.

Additional Tasks

• Perform additional tasks as assigned to support quality and business objectives.