Engineering (Non IT) and Research - Quality Engineer

Job Description: TITLE: Quality Engineer
REPORTS TO: Quality Assurance Manager
LOCATION: Eugene, Oregon
ROLE AND RESPONSIBILITIES
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, maintain and evaluate product/process trends, designing and participating in process and product improvement plans
Ensure risk assessment activities are completed for relevant processes/products (i.e. dFMEA, pFMEA)
Create and implement projects for quality improvement
Create quality documents aligned to regulations and practices, revise quality documentation to better define, improve, or clarify practices, process and/or product quality
Participate actively in Continuous Improvement programs
Participate in change control activities for documents and manufacturing processes
Participate in Product Development Process assuring design quality elements are maintained and compliant with ISO 13485 and applicable regulations (e.g., supply chain, design controls, verification and validation activities, review of quality control plan and product specifications)
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 in Chemistry, Biology, 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
ADDITIONAL NOTES
No relocation is available for this position.