Site Quality Engineer

1 day ago

Udaipur, Rajasthan, India Zigsaw Full time ₹ 6,00,000 - ₹ 12,00,000 per year
Overview: The Site Quality Engineer plays a crucial role in ensuring that all products and processes meet regulatory and quality standards at the designated site. They are responsible for implementing and maintaining quality assurance and control processes to drive continuous improvement and compliance with industry and company standards.Key Responsibilities:
  • Develop and implement quality control procedures to ensure products meet regulatory and customer requirements
  • Conduct root cause analysis and implement corrective actions for quality issues
  • Collaborate with cross-functional teams to drive quality improvements in manufacturing processes
  • Perform risk assessments and support the development of risk mitigation plans
  • Provide technical support for investigations related to product quality or process deviations
  • Conduct internal audits to ensure compliance with quality management systems
  • Participate in the review and approval of validation and qualification protocols and reports
  • Review and approve change controls and deviations related to product quality
  • Create and maintain quality documentation, including SOPs and work instructions
  • Support regulatory inspections and customer audits
  • Lead or support continuous improvement projects to enhance product quality and operational efficiency
  • Participate in the development and delivery of quality-related training programs
  • Monitor and analyze quality metrics to identify trends and areas for improvement
  • Conduct supplier audits and evaluations to ensure compliance with quality standards
  • Participate in the development and implementation of quality management systems
Required Qualifications:
  • Bachelor's degree in engineering or a related field
  • Proven experience in a quality engineering role within a regulated manufacturing environment
  • Strong knowledge of quality management systems, such as ISO 9001 and FDA regulations
  • Experience in conducting root cause analysis and implementing corrective and preventive actions
  • Proficiency in statistical analysis and data interpretation
  • Excellent problem-solving and decision-making skills
  • Ability to effectively communicate and collaborate with cross-functional teams
  • Experience in supporting regulatory inspections and customer audits
  • Solid understanding of validation and qualification processes
  • Ability to author and review technical documentation, including protocols, reports, and SOPs
  • Strong attention to detail and a commitment to maintaining high-quality standards
  • Knowledge of lean and Six Sigma methodologies is a plus
  • Professional certifications, such as CQE or CQA, are preferred
  • Ability to work independently and prioritize multiple tasks in a dynamic environment
  • Proficiency in MS Office applications and quality management software

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