Senior Quality Control Analyst

4 days ago


San Diego, California, United States Ignite Human Capital Full time

About the Role

We are seeking a Senior Quality Control Analyst to join our quality assurance team at Ignite Human Capital. The successful candidate will be responsible for overseeing key components of the quality system, focusing on supplier oversight, corrective actions, customer feedback, regulatory compliance, and product release processes.

Key Responsibilities

  • Conduct audits of suppliers as needed to ensure quality standards are met.
  • Develop, review, and validate standard operating procedures (SOPs), testing protocols, and compliance documentation to ensure adherence to regulatory requirements and internal guidelines.
  • Manage quality-related activities, including addressing deviations, non-conformities, and customer feedback.
  • Lead investigations for corrective and preventive actions (CAPAs).
  • Assess and document the impact of deviations and customer complaints on product quality.
  • Review and approve risk analyses related to engineering changes and recalls.
  • Oversee engineering change orders and maintain accurate documentation; collaborate with various teams to resolve quality-related issues.
  • Collaborate with manufacturing teams to integrate risk management practices and ensure compliance throughout the product development lifecycle.
  • Engage in both internal and external compliance audits.
  • Provide ongoing support and training to quality assurance team members.
  • Contribute to the development of training initiatives aimed at enhancing product quality.
  • Analyze quality metrics and trends for continuous improvement.

Requirements

  • Bachelor's degree in a relevant scientific field or equivalent experience; an engineering degree is preferred.
  • Minimum of 5 years in quality assurance, preferably within the biotech or medical device sectors, with experience in a regulated environment.

Benefits

We offer a competitive salary range of $90,000 - $120,000 per year, depending on experience, as well as a comprehensive benefits package including health insurance, retirement savings plan, and paid time off.



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