Site Quality Engineer - 31076

Overview:

Key Responsibilities:

• Develop and maintain quality systems and procedures
• Conduct root cause analysis for quality nonconformances
• Provide guidance on quality assurance principles and best practices
• Conduct internal and external audits to ensure compliance with ISO standards
• Implement corrective and preventative actions to address quality issues
• Analyze quality data and trends to identify areas for improvement
• Collaborate with crossfunctional teams to drive continuous improvement
• Lead and support quality improvement projects
• Ensure timely resolution of customer complaints
• Conduct training on qualityrelated topics for staff
• Participate in new product development and change management processes
• Monitor and report on key quality performance indicators
• Support regulatory inspections and customer audits
• Champion a culture of quality consciousness and accountability

Required Qualifications:

• Bachelors degree in Engineering Quality Management or related field
• 3 years of experience in a quality engineering role
• Proficient in quality management tools and methodologies
• Strong understanding of ISO standards and regulatory requirements
• Experience in conducting root cause analysis and implementing corrective actions
• Knowledge of statistical analysis and quality control techniques
• Excellent problemsolving and decisionmaking skills
• Ability to communicate effectively across all levels of the organization
• Certification in quality management systems (e.g. Six Sigma ASQ) is a plus
• Experience in the pharmaceutical or medical device industry is preferred
• Detailoriented with a passion for driving continuous improvement
• Ability to work independently and as part of a team
• Proficient in MS Office and quality management software
• Strong project management and organizational skills
• Adherence to ethical and professional standards

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