Job Title: Quality Engineer

Position Summary

We are seeking a detail-oriented Quality Engineer to ensure product and process quality through effective implementation of quality systems, continuous improvement initiatives, and compliance with regulatory and customer requirements. The ideal candidate will have experience in quality assurance, process validation, and root cause analysis in a regulated or manufacturing environment.

Key Responsibilities

• Develop, implement, and maintain quality systems and procedures
• Perform root cause analysis (RCA) and drive corrective/preventive actions (CAPA)
• Support process validation activities (IQ/OQ/PQ) and continuous process improvement
• Review and approve quality documentation , including SOPs, work instructions, and reports
• Lead or support internal audits, external audits, and regulatory inspections
• Ensure compliance with industry standards (ISO, FDA, cGMP, etc.)
• Analyze quality data and implement improvements to reduce defects and improve efficiency
• Collaborate with cross-functional teams (Manufacturing, Engineering, QA/QC, R&D)
• Handle non-conformances, deviations, and change control processes
• Support supplier quality activities and incoming inspections

Required Qualifications

• Bachelor’s degree in Engineering (Mechanical, Industrial, Biomedical, Chemical, or related)
• 3–8+ years of experience in a quality engineering or quality assurance role
• Strong knowledge of quality systems, CAPA, and root cause analysis tools
• Experience working in a regulated environment (FDA, ISO, GMP)
• Hands-on experience with process validation (IQ/OQ/PQ)

Preferred Qualifications

• Experience in medical device, pharmaceutical, or manufacturing industries
• Knowledge of ISO 13485, ISO 9001, or FDA 21 CFR regulations
• Familiarity with Lean, Six Sigma, FMEA, SPC tools
• Experience with audit support and supplier quality management
• Certification such as CQE (Certified Quality Engineer) is a plus