Engineering (Non IT) and Research - Quality Engineer II

Job Description
Client: Biotechnology
Title: Quality Engineer II
Location: Eugene, OR - 97402
Duration: 06 months (+Possibilities of extension)
We are the world leader in serving science, with annual revenue of approximately *** billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands
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 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.
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 site's 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%
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
Please provide 1-5 pre-screening questions:
1. Tell me about your contribution specific to Quality or protecting the customer's interest on a high-impact project.
2. Describe any customer-facing experience you may have.
3. Describe your familiarity with Finished Goods Manufacturing:
4. Describe your familiarity with complaint resolution:
5. Describe your familiarity with Product non-conformances and deviations:
6. Describe your familiarity with Process Improvement projects:
7. What types of teams have you worked on in the past? (Large/Small/independent)
8. Are you currently working or immediately available?
9. Are you willing to work 100% onsite everyday?