Quality Engineer - Medical Devices #206471

Location:    OR - Eugene, OR

Job Title:    Quality Engineer II

Pay Rate: $25 to $35.00

Duration: May 14, 2023 to Nov 13, 2023 (184 Days) (6 Months)

WORK HOURS: Full-Time; 8:00am - 5:00pm.

SUMMARY:

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.

RESPONSIBILITIES:

 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.

REQUIRED EXPERIENCE:

 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 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.

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