Sr. Quality Engineer

Evergen-posted 3 months ago
West Lafayette, IN
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RTI Surgical is now Evergen! This rebranding reflects our strategic evolution as a leading CDMO in regenerative medicine and comes at the end of a significant year for the business, including the successful acquisitions of Cook Biotech in IN. and Collagen Solutions, MN. Our new brand identity emphasizes our unique positioning as the only CDMO offering a comprehensive portfolio of allograft and xenograft biomaterials at scale. Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, Evergen is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN., Eden Prairie and Glencoe, MN., Neunkirchen, DE., Glasgow, UK., and Marton, NZ.

  • 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.
  • 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.
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