Quality Engineer

About This Role

The Quality Engineer I develops, implements, and maintains Quality System requirements across manufacturing, supplier management, and process validation. This role is crucial for ensuring product quality and compliance, involving a range of activities from auditing to risk assessment and continuous improvement.

Responsibilities

• Develop, implement and maintain Quality System requirements on assigned areas of manufacturing, supplier management, and process validation
• Know and follow all laws and policies that apply to one’s job and maintain the highest levels of professionalism, ethics and compliance at all times
• Communicate and resolve quality issues and apply root cause analysis to drive corrective and preventive actions
• Work on continuous improvement activities, which may include participating in, and/or leading Quality Improvement Teams
• Provide quality reports and review trending on assigned areas of responsibility
• Conduct failure investigations and problem analysis regarding customer complaints, stock evaluations, supplier quality issues, calibration out of tolerance conditions, and CAPAs (internal or audit CAPAs)
• Review and approve documents and drawings for manufacturing and product development (DCOs, MCs)
• Support Engineering, Manufacturing, Materials, Inspection, Distribution and/or Product Development Groups in order to assure quality and compliance of products
• Design gauging and develop tools and techniques to measure product parameters to assure product complies with engineering drawings
• Recommend, acquire and validate the necessary tools, equipment and technologies to support inspection and testing activities
• Develop and document Quality Plans to support product acceptance activities
• Facilitate creation of risk management documents
• Ensure compliance issues are addressed for product activities
• Participate on design reviews and risk analysis for product changes
• Provide process validation program oversight to ensure adequacy of validation activities and documentation in terms of regulatory compliance and technical/statistical soundness
• Review, assess and evaluate validation protocols (IQ, OQ, PQ) for compliance to procedures and regulations, statistical validity and approval
• Provide guidance to others for the generation of clear, concise and defendable protocols and reports
• Assist in determination of the need for validation
• Manage process monitoring activities including tracking, data collection and analysis, corrective action, and reporting
• Manage supplier validation activities including supplier assessment, protocol development, and generation of supplier validation master plan(s)
• Coordinate and participate on supplier audits and technical assessments