Quality Assurance Engineer- Non IT

Kelly Engineering is looking to hire a Quality Engineer for our client in Eugene, Oregon.

Duration: 6 months(onsite)

Rate: $25-28/hr depending on experience (min 1 year experience is must)

The Quality Engineer (QE) supports production activities, complaint handling, and improvement activities of the Finished Goods Manufacturing work center. The Finished Good Manufacturing team is responsible for the formulation, kitting and packaging of fluorescent dye products manufactured at the Eugene, Oregon campus. The QE will be an active contributor to a fast-paced and energetic Quality Assurance team.

What will you do?

• Drive complaints from internal and/or external customers to resolution in a timely manner

• Investigate, analyze and correct non-conformances (internal, external and systemic issues)

• Analyze processes or products, collaborate with Manufacturing to investigate trends, conduct root cause analysis and lead corrective actions, ensuring their effectiveness

• Collect, analyze, and present Quality data to build and implement projects for improvement

• Ensure risk assessments are complete for the processes and products (e.g. pFMEA) supporting the finished goods production team

• Recommend product revisions, process changes, and testing procedures to assure that quality standards are being attained

• Create quality documents aligned to regulations and practices, revise quality documentation to better define, improve, or clarify practices, process and/or product quality

• Participate as internal auditor, and participate in external audits

• Participate actively in Continuous Improvement programs

• Participate in change control activities for documents and manufacturing processes

• 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

• 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 those for document control, CAPA and ERP

• Strong analytical and problem-solving skills with attention to details

• Able to motivate and positively influence peers

• Able to resolve rapidly common inquiries or complaints from internal and/or external customers

• Able to effectively present information to colleagues and customers

• Able to read, analyze, and interpret common scientific data and QMS standards

(Quality Experience, Microsoft Office, knowledge of ISO standards (does not need to be ISO 13485), complaint and nonconforming material handling, Good Documentation Practices, Effective Communicator)