Description

  • A Senior Quality Assurance Engineer assures products, processes, and quality records conform to quality standards and establishes compliance with the quality system. 
  • Responsible for maintaining a strong collaborative partnership with cross-functional team members.
  • Lead on-time completion of Quality Assurance (QA) engineering deliverables.
  • Accountable for leadership, decision making, and oversight of the quality systems, including CAPA (Corrective and Preventive Action) systems.
  • Works with and influences key stakeholders to develop and maintain QA procedures, forms, and systems.
  • Develop and lead training for QA systems.
  • Influence and guide other team members with product review and analysis for QA activities.
  • Maintain databases and record storage for QA systems.
  • Process QA requests, ensuring owners are assigned, and timely responses are provided in alignment with quality goals.
  • Lead meetings and communications for QA system information, concerns, and updates.
  • Lead and mentor others with QA data analysis, trending, and reporting. 
  • High proficiency with reporting and publishing weekly, monthly, and quarterly metrics.
  • Track and proactively identify concerns manufacturing related complaints in alignment with SJM goals.
  • Plan and prevent potential system issues.
  • Lead Global CAPA team with training, CAPA oversight, and CAPA deliverables. Proficient as lead representative for presenting QA System to internal and external auditors.
  • Investigate and resolve system nonconformances and concerns (defined during internal and external audits).
  • As appropriate, it leads in the completion of risk assessment, as related to QA systems.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  •  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Performs other related duties and responsibilities, on occasion, as assigned

Key Skills
Education

Any Gradute

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