Quality Engineer

Job Summary

We 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. The ideal candidate will have strong knowledge of quality systems, risk management, and 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 ISO9001 & ISO 13485 and regulatory requirements.

• Candidates should demonstrate hands-on experience with:

o ISO 13485 Quality Management Systems

o FDA QSR (21 CFR Part 820)

o ISO 14971 Risk Management

o Good Manufacturing Practices (GMP)

o Medical Device Design Controls

o Validation Requirements (IQ/OQ/PQ)

• 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:

o ISO 13485

o FDA 21 CFR Part 820

o ISO 14971 (Risk Management)

o 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