Job Summary
The Product Quality Engineer is responsible for ensuring that products meet established quality standards, regulatory requirements, and customer expectations. This role focuses on process control, nonconformance management, CAPA, and continuous improvement in compliance with ISO 13485 and applicable regulatory requirements for medical devices.
Key Responsibilities
Quality System & Regulatory Compliance
- Ensure compliance with ISO 13485, applicable dental device regulations, and internal quality procedures.
- Support internal and external audits (regulatory, certification body, and customer audits).
- Participate in risk management activities in accordance with ISO 14971 (process and product risk).
- Ensure proper documentation and record control for product quality activities.
Product & Process Quality
- Monitor and control quality of processes.
- Establish and maintain process controls, acceptance criteria, and inspection plans.
- Review and approve work instructions and quality checkpoints.
- Conduct root cause analysis and implement corrective actions for process deviations and defects.
Nonconformance & CAPA
- Lead investigation of product and process nonconformances.
- Perform and assist on root cause analysis using structured methods (5-Why, Fishbone, etc.).
- Define, implement, and verify Corrective and Preventive Actions (CAPA).
- Trend quality data (scrap, rework, defects) and drive improvement projects.
Supplier & Incoming Quality
- Support supplier qualification and monitoring materials.
Validation & Change Control
- Support or lead validation activities for:
- Manufacturing processes
- Software used in design/production
- Equipment (IQ/OQ/PQ where applicable)
- Evaluate quality impact of changes through formal change control and risk assessment.
Training & Support
- Provide quality training on procedures, defect prevention, risk management, and problem solving.
- Support production teams in resolving quality issues in real time.
Qualifications
- Bachelor's degree in engineering (Biomedical, Industrial, Mechanical, Electronics, Chemical or related field).
- 2–5 years of experience in quality engineering or quality assurance in:
Medical device or life science manufacturing or Dental lab / dental device production or Electronics or Semiconductor manufacturing from a MNC.
- Hands-on experience with ISO 13485 quality systems.
- Experience with nonconformance investigation and CAPA management.
