Quality Assurance Engineer II

A leading global pharmaceutical and medical technology company to hire a Quality Assurance Engineer II . This is an exciting opportunity for a quality professional with experience in manufacturing, process improvement, audits, and quality systems.

Key Responsibilities

• Develop, maintain, and implement quality requirements and standards.
• Serve as the primary quality resource for problem identification, resolution, and continuous improvement activities.
• Support equipment, process, and test method qualification/validation projects.
• Design and implement process controls, testing, inspection, and quality improvement methods.
• Develop and maintain quality documentation, reports, and quality plans.
• Participate in internal and external quality audits.
• Investigate quality issues, perform root cause analysis, and implement corrective actions (CAPA).
• Monitor quality trends and report key quality metrics.
• Support process certification and compliance initiatives.
• Drive product and process improvements to enhance customer satisfaction.

Required Qualifications

• Bachelor's degree in mechanical engineering or a related engineering discipline.
• Experience in Quality Assurance/Quality Engineering within a manufacturing environment.
• Knowledge of quality systems and standards such as ISO 9001, ASQ, ISO 14001, QS 9100 , or similar.
• Experience with audits, root cause analysis, corrective actions, and process validation.
• Strong problem-solving and analytical skills.
• Proficiency in Microsoft Office, including Excel and Word.