Quality Control Manager

The Quality Head is responsible for leading and managing all Quality Assurance (QA) and Quality Control (QC) activities to ensure products consistently meet customer requirements, regulatory standards, and company quality objectives. The role oversees quality systems, process compliance, audits, continuous improvement initiatives, customer complaints, CAPA management, and quality team performance across all manufacturing operations.

Key Responsibilities: Quality Management System (QMS) Develop, implement, and maintain the company Quality Management System.

Ensure compliance with ISO, GMP,and regulatory requirements.

Maintain quality procedures, SOPs, forms, and records.

Lead document control and quality system updates.

Quality Assurance Oversight Ensure all manufacturing processes comply with approved standards.

Monitor adherence to process controls and specifications.

Review and approve quality procedures and work instructions.

Ensure product traceability and batch documentation accuracy.

Quality Control Management Supervise QC activities across all production stages. Ensure inspections and testing are completed according to standards. Monitor defect trends and quality performance indicators. Approve product release or rejection decisions.

Customer Complaints & CAPA Lead investigations for customer complaints and nonconformities.

Conduct Root Cause Analysis (RCA).

Ensure effective Corrective and Preventive Actions (CAPA) implementation.

Monitor effectiveness of corrective actions.

Audit & Compliance Management Lead internal quality audits.

Coordinate external audits and customer audits.

Ensure audit findings are addressed and closed on time.

Maintain audit readiness at all times.

Continuous Improvement Drive continuous improvement initiatives across production and quality processes.

Analyze quality data and identify improvement opportunities.

Reduce defects, rework, and process variation.

Support Lean Manufacturing and operational excellence initiatives.

Team Leadership Lead and develop QA/QC teams.

Set departmental objectives and KPIs.

Conduct performance evaluations and training plans.

Set departmental objectives and KPIs.

Build a strong quality culture within the organization.

Supplier & Incoming Quality Monitor supplier quality performance.

Approve incoming material inspection standards.

Support supplier corrective action activities.

Coordinate supplier quality improvement programs.

Reporting & Analysis: Prepare and review reports including: Customer complaints

NCRs (Non-Conformance Reports)

CAPA status

Defect rates

Scrap/rework trends

Audit findings

Process capability

Quality KPIs

Present quality performance to management regularly.

Regulatory & Risk Management Ensure compliance with applicable medical device / manufacturing regulations.

Participate in risk assessments and FMEA activities.

Support validation and change control processes.

Ensure proper handling of deviations and nonconformities.

Required Qualifications & Skills: Bachelor’s degree in Science Engineering or equivalent

Basic computer skills (Excel, ERP/MRP systems).

Attention to detail and ability to work under pressure.

Knowledge of manufacturing or dental industry data systems is a plus.