Quality Engineer (Medical Devices)

Job Summary

The ideal candidate will have strong knowledge of quality systems, risk management, anWe are seeking a detail-oriented Quality Engineer with experience in the medical device or healthcare products industry to ensure compliance with regulatory standards and drive continuous improvement in product quality and manufacturing processes. d regulatory requirements such as ISO 13485, FDA QSR (21 CFR Part 820), and GMP.

Key Responsibilities

• Support and maintain the Quality Management System (QMS) in compliance with ISO 13485 and regulatory requirements.
• Lead and support CAPA (Corrective and Preventive Actions) investigations, root cause analysis, and effectiveness checks.
• Perform Internal Audits, Supplier Audits, and support external regulatory audits (FDA, notified bodies).
• Review and approve design documentation, including DHF (Design History File), DMR (Device Master Record), and DHR (Device History Record).
• Participate in risk management activities (ISO 14971), including hazard analysis, FMEA, and risk control implementation.
• Collaborate with cross-functional teams (R&D, Manufacturing, Regulatory Affairs) for new product development and process validation.
• Ensure compliance with Good Manufacturing Practices (GMP) and quality standards.
• Handle non-conformance reports (NCR) and lead investigations for product or process deviations.
• Support validation activities (IQ/OQ/PQ, software validation, process validation).
• Drive supplier quality management, including qualification, monitoring, and performance evaluation.
• Analyze quality data and implement continuous improvement initiatives (Lean, Six Sigma).

Required Qualifications

• Bachelor’s degree in Engineering, Biomedical, Life Sciences, or related field.

• 3–8 years of experience in quality engineering within the medical device/pharmaceutical/healthcare industry.

• Strong working knowledge of:

  • ISO 13485
  • FDA 21 CFR Part 820
  • ISO 14971 (Risk Management)
  • GMP requirements

• Experience with CAPA, audits, validation, and document control systems.

• Familiarity with statistical tools and quality methodologies (SPC, Six Sigma, Root Cause Analysis).

• Excellent problem-solving, analytical, and communication skills.

Preferred Qualifications

• Certification such as Certified Quality Engineer (CQE) or Six Sigma Green Belt/Black Belt will added advantage
• Experience with sterile products, combination products, or Class II/III medical devices.
• Knowledge of regulatory submissions (e.g., 510(k), CE Marking).
• Experience with electronic QMS systems
• Experience in supplier quality management.
• Experience in HLA (and High Level Assembly Manufacturing) SMT (PCBA manufacturing)

Key Competencies

• Attention to detail and compliance mindset
• Strong analytical and investigative skills
• Cross-functional collaboration
• Effective communication and documentation
• Continuous improvement mindset

Work Environment

• Office and manufacturing floor interaction
• May require participation in audits, inspections, and supplier visits

Example KPIs

• CAPA closure timelines
• Audit findings and compliance scores
• Reduction in non-conformances
• Process improvement metrics
• Supplier quality performance