About the role

  • 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.
  • Excellent verbal and written communication
  • Technical writing
  • Problem solving methodologies
  • Microsoft Office Suite
  • Quality Management System software
  • Investigations

Benefits

  • Relocation bonus offered!

Job title

Senior Quality Engineer

Job type

Experience level

Senior

Salary

$100,000 - $120,000 per year

Degree requirement

Bachelor's Degree

Location requirements

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