Manufacturing Quality Engineer

The ideal candidate will drive quality improvements, investigate non-conformances, lead root cause analysis activities, and collaborate with cross-functional teams to maintain a robust Quality Management System (QMS). Lead root cause investigations using methodologies such as 5 Whys, Fishbone, Pareto Analysis, and FMEA.

Job Description:
We are seeking a Manufacturing Quality Engineer to support manufacturing operations by ensuring products meet quality standards, regulatory requirements, and customer expectations. The ideal candidate will drive quality improvements, investigate non-conformances, lead root cause analysis activities, and collaborate with cross-functional teams to maintain a robust Quality Management System (QMS).
Responsibilities:

• Support daily manufacturing operations to ensure compliance with quality standards and procedures.
• Investigate product defects, non-conformances, deviations, and customer complaints.
• Lead root cause investigations using methodologies such as 5 Whys, Fishbone, Pareto Analysis, and FMEA.
• Develop, implement, and monitor Corrective and Preventive Actions (CAPA).
• Analyze quality metrics and identify opportunities for continuous improvement.
• Review and approve manufacturing procedures, work instructions, SOPs, and quality documentation.
• Support process validation, equipment qualification, and change control activities.
• Conduct internal audits and participate in customer, regulatory, and certification audits.
• Collaborate with Manufacturing, Engineering, Supply Chain, Operations, and Quality teams.
• Monitor Statistical Process Control (SPC) data and implement process improvements.
• Ensure compliance with applicable regulations and quality standards.
• Support risk management and quality planning activities.

Requirements:

• Bachelor's degree in mechanical, Industrial, Manufacturing, Biomedical Engineering.
• 3+ years of experience in Quality Engineering, Manufacturing Quality, or Quality Assurance.
• Experience in a manufacturing environment.

Required Skills:

• Quality Management Systems (QMS).
• CAPA Management.
• Root Cause Analysis.
• Non-Conformance Management.
• Change Control.
• Statistical Process Control (SPC).
• FMEA (Failure Mode and Effects Analysis).
• Risk Management.
• Process Improvement.
• Data Analysis and Reporting.
• Technical Documentation.

Preferred Qualifications:

• Experience with:
  • ISO 9001
  • ISO 13485
  • AS9100
  • IATF 16949
  • GMP/GxP environments
• Knowledge of Lean Manufacturing and Six Sigma methodologies.
• Experience with validation and qualification activities.
• ASQ certifications such as American Society for Quality CQE or CQA preferred.