Quality Engineer supporting product development and quality assurance at Evergen. Leading investigations, supporting supplier qualifications, and ensuring compliance with standards.
Responsibilities
Develops strong network of cross-functional colleagues, a deep understanding of business goals, project prioritization, and strong communication and facilitation skills to support the Quality Assurance function.
Supports product development processes inclusive of review and approval of design project deliverables, collaboration with core teams, and review and approval of risk management deliverables
Leads investigations for product nonconformances, process noncompliance issues, documents these appropriately in the Corrective Action / Preventive Action (CAPA) system, and demonstrates good judgment in selecting methods and techniques for obtaining solutions
Participates in risk assessment, review, and disposition of nonconforming products including complaints
Performs CAPA activities inclusive of root cause analysis, investigations, product and process disposition, risk management, and effectiveness check
Supports supplier qualification activities inclusive of completing and maintaining supplier qualifications, working with suppliers to address corrective actions, performing supplier audits, and assessing supplier risk
Supports validation activities inclusive of reviewing and approving validation protocols and reports
Interprets and applies appropriate sampling plans and statistical techniques
Ensures proper change control including initiating change plans, updating Work Instructions and Standard Operating Procedures, and documentation approvals
Directly supports the quality systems and process improvement initiatives
Supports and performs internal and external audits
Other duties as assigned
Requirements
Bachelor’s degree in Engineering or relevant technical discipline
Minimum of 6 years of quality or engineering experience required.
Experience may be substituted for education requirements.
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