Quality Engineer Jobs

Job Title: Quality Engineer II

Location: Eugene OR 97402

Contract: 6+ Months

Pay rate: $25/hrs. - $30/hrs.

Shift: 8 am – 5 pm

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 site’s 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.

Responsibilities:

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

Education:

• Strong computer skills (MS Word, MS Excel, MS PowerPoint)
• 2-5 years experience in the Quality Assurance field required
• Knowledge of Quality Assurance and/or Quality Systems, including standards such as ISO 13485 Medical Devices – Quality Management System
• 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

Knowledge, Skills, Abilities:

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

“We are an equal opportunity employer. It is our policy to provide employment, compensation, and other benefits related to employment without regard to race, color, religion, sex, gender, national or ethnic origin, disability, veteran status, age, genetic information, citizenship, or any other basis prohibited by applicable federal, state, or local law.”