Senior Quality Engineer - Medical Device - Job ID: 179975

Medix™; Redmond (OR); On-site; USD 110,000 - 150,000; Full time

Job summary

A leading health staffing firm is seeking a Senior Quality Engineer for a full-time role in the Redmond, OR area. The position involves leading investigations into non-conformances in medical devices and collaborating with suppliers. Candidates should have a Bachelor's degree in a relevant field and at least 5 years of industry experience, along with advanced skills in quality assurance and data analysis.

Qualifications

• Minimum 5 years of experience in Medical Devices, Drugs, or life sciences.
• Experience with quality assurance codes and standards (21 CFR 820, ISO13485).
• Ability to work independently and achieve goals.
• Ability to work with minimal supervision.
• Strong Excel skills (Pivot tables, formulas).
• Six Sigma/Lean knowledge is a plus.

Responsibilities

• Lead investigations into product and process non-conformances.
• Design experiments to identify sources of variation.
• Coordinate product testing with labs as necessary.
• Develop methods for process control, validation, and improvement.
• Support product development, design control, risk management, and CE files.
• Coordinate product testing with internal and external labs.

Skills

Quality assurance

Process improvement

Problem-solving

Data analysis

Regulatory compliance

CE technical files knowledge

Advanced Excel

Education

Bachelor's degree in Engineering, Science, Math, or a related field

Tools

Microsoft Excel

Job description

Overview

Senior Quality Engineer - Medical Device - Job ID: 179975. This contract-to-hire opportunity is through Medix. Location: Redmond, OR area.

Key Responsibilities

• 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.

What You\'ll Bring

• 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, ISO13485).
• 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.

Employment Type

• Full-time