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
- Posted On: 15+ Days Ago
- Experience: 5+ years of experience
- Openings: 1
- Category: Senior Quality Engineer
- Tenure: Contract - Corp-to-Corp Position