Senior Quality Engineer - Medical Device

Overview

Senior Quality Engineer - Medical Device - Job . This contract-to-hire opportunity is through Medix.

Location:

Redmond, OR area.

• Lead investigations into product and process non-conformances and out-of-specification results, developing effective corrective and preventive actions (CAPA).
• Design complex experiments to pinpoint sources of variation affecting products and processes.
• Direct and collaborate with suppliers on quality problems, making sure effective corrective actions are implemented.
• Manage the development of methods for process control, validation, and improvement.
• Provide your quality expertise for product development, design control activities, risk management, and CE technical files.
• Coordinate product testing with internal and external labs as needed.

• A Bachelor s degree in Engineering, Science, Math, or a related technical field
• At least 5 years of industry experience in Medical Devices, Drugs, and/or fields directly related to the life science industry.
• Experience applying knowledge of government and industry quality assurance codes and standards (e.g., 21 CFR 820, ISO
  13485).
• A track record of accomplishing goals with little to no supervision.
• Advanced skills in Microsoft Excel (e.g., Pivot tables, conditional formatting, formulas).
• Knowledge of advanced Six Sigma/Lean concepts is a plus.

• Full-time