Job Summary:

We are seeking a Quality Systems Engineer to develop, implement, and maintain our quality management systems (QMS) to ensure compliance with industry standards and regulatory requirements. The ideal candidate will have a strong background in quality engineering, process improvement, and auditing, with a focus on driving continuous improvement and operational excellence.

Key Responsibilities:

• Quality Management System (QMS): Develop, implement, and maintain QMS in accordance with ISO 9001 and/or other relevant industry standards.

• Compliance & Auditing: Conduct internal and external audits to ensure adherence to regulatory requirements, company policies, and customer expectations.

• Process Improvement: Identify, analyze, and improve quality processes using methodologies like Lean, Six Sigma, or Kaizen.

• CAPA (Corrective & Preventive Actions): Investigate quality issues, lead root cause analysis, and implement corrective and preventive measures.

• Documentation & Reporting: Maintain quality records, prepare reports, and ensure all documentation aligns with regulatory and company standards.

• Supplier Quality Management: Collaborate with suppliers to ensure product quality and compliance with standards.

• Risk Management: Identify potential risks in processes and implement mitigation strategies to enhance product reliability.

• Training & Support: Provide training and guidance on quality system procedures, best practices, and compliance requirements.

Qualifications:

• Bachelor’s degree in Engineering, Quality Management, or a related field.

• 2+ years of experience in quality systems engineering, manufacturing, or a regulated industry.

• Strong knowledge of ISO 9001.

• Experience with root cause analysis tools (5 Whys, Fishbone, FMEA, etc.).

• Proficiency in statistical analysis and quality management software.

• Strong problem-solving skills and ability to lead cross-functional teams.

• Excellent communication and project management skills.

Preferred Skills:

• Certified Quality Engineer (CQE), Six Sigma Green/Black Belt, or Internal Auditor certification.

• Experience with Lean Manufacturing and continuous improvement initiatives.

• Familiarity with ERP/MRP systems and data analytics for quality metrics.