Senior Quality Engineer
Evergen (Formerly RTI Surgical)
full-time
Posted on:
Location Type: Office
Location: West Lafayette • United States
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Salary
💰 $100,000 - $120,000 per year
Job Level
About the role
- 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!
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
root cause analysisrisk managementstatistical techniquestechnical writingquality management systemCAPAprocess improvementsupplier auditsvalidation protocolsdesign project deliverables
Soft Skills
communicationfacilitationproblem solvingjudgmentcollaborationproject prioritizationinvestigationdocumentationchange controlinterpersonal skills