Quality Engineer II

Company: Integrated Resources, Inc
Location: Eugene
Posted on: May 23, 2023

Job Description:

Job Title: Quality Assurance Engineer II
Location/Division Specific Information: This position is located at our Eugene, OR facility.

How will you make an impact?
The Quality Engineer (QE) is responsible for management and oversight of all validation, preventive maintenance, and calibration activities to support site activities. The QE will be involved in preparing and implementing validation protocols and reports, and supporting on-time preventive maintenance and calibration. For all projects worked on, active participation and leadership is expected in the origination of design concepts, design specifications, design for quality and manufacturing requirements, project planning, and applicable documentation. The QE develops, modifies, applies and maintains quality standards, and generates protocols and reports. The QE provides mentoring and coaching to Manufacturing, R&D and support personnel on Quality System Requirements and process improvement methodologies for the sites products and processes. The QE will also support the Organic Production department, managing nonconforming material, investigations, process improvements through effective corrective actions, and leading material review board meetings.

What will you do?
Direct and improve validation activities for the facility, including maintenance of the Validation Master Plan
Perform, evaluate and analyze validation protocols and associated data for compliance with site procedures and ISO guidelines
Evaluate and analyze validation data collected during projects, verify adequacy of the data and compliance with Quality System and regulatory requirements
Actively partner with Manufacturing and supporting departments on special projects to create and revise qualification and validation protocols, studies, or other improvement projects
Facilitate supplier visits related to validation, calibration, preventive and corrective maintenance as required
Support the Facilities department to capture Quality related and validation activities
Participate in and support change control activities for documents and manufacturing processes
Oversee the execution of the sites preventive maintenance and calibration program, ensuring that OOTs are promptly resolved and risk assessments performed
Investigate, analyze and correct process non-conformances (internal, external and systemic issues)
Actively seek, create and implement projects for quality improvement
Collect, analyze, and present Quality data
Define, drive, and execute process and product improvement plans and ensure their effectiveness
Participate as internal auditor, and participate in external audits
Has a proactive and process-driven approach to problem solving
Able to define problems, collect data, establish facts, and draw valid conclusions
Investigate organic material failures with the support of technical team
Eliminate root causes through effective corrective actions
Other duties may be assigned, as required
Travel requirement: 0-10%


How will you get here?
Education
BS in Chemistry, Biology, or Engineering (Chemical, Biomedical, Industrial, Mechanical or Quality) or BS with other demonstrated equivalent work experience in the Quality Systems area pertaining to a scientific industry
2-5 years experience in the Quality Assurance field required
Strong computer skills (MS Word, MS Excel, MS PowerPoint)
Knowledge of Quality Assurance and/or Quality Systems, including standards such as ISO 13485 Medical Devices Quality Management System

Knowledge, Skills, Abilities
Knowledge of Operations and manufacturing processes
Familiar with enterprise software systems including Agile, TrackWise, SAP-LMS
Knowledge of statistical data analysis methods and tools (e.g. JMP, Minitab)
Able to motivate and positively influence peers
Able to resolve rapidly common or complex inquiries or complaints from internal and/or external customers and regulatory agencies
Able to effectively present information to groups of employees, site leadership, and customers
Able to read, analyze, and interpret common scientific data and QMS standards
Able to manage and lead a cross functional team

Keywords: Integrated Resources, Inc, Eugene , Quality Engineer II, Engineering , Eugene, Oregon