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Quality Engineer

Integrated Resources, Inc

Eugene, OR

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JOB DETAILS
SALARY
SKILLS
American Society for Quality (ASQ), Analysis Skills, Biology, Biomedicine, Certified Quality Engineer (CQE), Change Control, Chemical Engineering, Chemistry, Control Systems, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Data Collection, Document Control, Document Management, Documentation, Enterprise Applications, Healthcare Software, ISO (International Organization for Standardization), ISO 9001, Laboratory, Leadership, Manufacturing, Manufacturing Operations, Manufacturing/Industrial Processes, Medical Equipment, Presentation/Verbal Skills, Quality Engineering, Quality Management, Quality System Requirements (QSR), Regulations, Regulatory Requirements, Risk Management, Root Cause Analysis, Willing to Travel
LOCATION
Eugene, OR
POSTED
3 days ago
Pay: $29/Hour on W2

Description:
"Actively partner with Manufacturing departments, providing tactical Quality support to the teams
"Investigate, analyze and correct non-conformances (internal, external and systemic issues)
"Lead root cause analysis, implement/provide corrective actions and ensure their effectiveness
"Collect, analyze, and present Quality data
"Create quality documents aligned to regulations and practices, revise quality documentation to better define, improve, or clarify practices, process and/or product quality
"Participate in change control activities for documents and manufacturing processes
"Support eDMS system with processing document change requests related to Quality System documents
"Laboratory experiments, as required
"Other duties may be assigned, as required
"Travel requirement: 0-10%

QUALIFICATIONS AND EDUCATION REQUIREMENTS
"1+ year experience in a Quality Engineering position familiarity with and execution of principles within Certified Quality Engineer (ASQ CQE) Body of Knowledge
"BS Biology, Chemistry, or Engineering (Chemical, Biomedical, Industrial, Mechanical or Quality) or demonstrated equivalent work experience in the Quality Engineering area pertaining to a scientific industry
"Knowledge in standards such as ISO 13485:2016 Medical Devices Quality Management Systems Requirements for Regulatory Purposes, ISO 9001:2015 Quality Management Systems, and ISO 14971 Medical Devices Risk Management.

PREFERRED SKILLS
"Knowledge of Operations and manufacturing processes
"Scientific laboratory experience highly desired
"Familiarity with enterprise software systems including ERPs, electronic document control systems, CAPA and training software packages
"Able to motivate and positively influence peers
"Ability to read, analyze, and interpret common scientific and technical data and QMS standards
"Ability to resolve rapidly common inquiries or complaints from internal and/or external customers and regulatory agencies
"Ability to effectively present information to groups of employees, site leadership, and customers
"Ability to define problems, collect data, establish facts, and draw valid conclusions

About the Company

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Integrated Resources, Inc

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