Quality Engineer

Quality Engineer

The experienced Quality Engineer is tasked with supporting ongoing quality efforts by fostering strong relationships with critical customers and collaborating with project management and manufacturing engineers. This role involves supporting new product introductions, ongoing validation, and planning and executing training based on business needs.

Responsibilities

• Provide and document training on standard work instructions, policies, and procedures.

• Utilize quality tools to implement improvements, including process flowcharting, Pareto analysis, correlation and regression analysis, significance tests, design of experiments, statistical process control, gauge repeatability and reproducibility, and trend analysis techniques.

• Act as a customer liaison and process customer quality complaints.

• Collect, analyze, and present data using statistical methodology.

• Assist suppliers with the interpretation of quality requirements.

• Aid in the development of essential QMS deliverables/Advanced Product Quality Planning (APQP), including complaint analysis, risk analysis, failure mode and effects analysis, CAPA, and process/equipment/software verification/validation.

• Plan and/or conduct process and equipment validations and special validations, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

• Determine machine and/or process capability through planning and/or executing Process Capability studies.

• Develop inspection criteria that connect customer requirements and manufacturing processes, identifying key characteristics, associated sampling plans, and required gauging.

• Interface with appropriate customer contacts to clarify customer requirements.

• Conceive and/or lead productivity improvements and/or continuous improvement projects.

• Monitor engineering production processes and products for adherence to internal and external requirements and practices.

• Participate in pre- and post-production launch reviews, providing quality engineering support.

• Perform quality reviews and internal audits; evaluate data and write associated reports.

• Recommend modifications to existing quality or production standards to achieve optimum quality within equipment capability limits.

• Review and approve product/process and document change requests.

• Review drawings to evaluate quality requirements, including correct application of geometric dimensioning and tolerance, proper use of process and material specifications, and key characteristics for inspection plans and gauging techniques.

• Support measuring and analyzing key metrics to monitor performance.

• Work with cross-functional teams to solve production and quality problems.

• Create and manage the overall course structure and set up course programs based on specifications.

• Reinforce safety expectations and ensure safety operating practices are demonstrated.

• Report issues or concerns to the supervisor.

• Support quality and compliance by adhering to all procedures, work instructions, and forms per the Quality Management Systems (QMS).

Essential Skills

• Expertise in CAPA (Corrective and Preventive Actions).

• Experience in equipment, process, parts, and new product validations.

• Proficiency in new product introduction processes.

• Strong background in quality engineering.

• Knowledge of ISO standards.

• Ability to perform root cause analysis.

• Experience with medical devices.

Additional Skills & Qualifications

• Bachelor of Science degree.

• Minimum of 5 years of experience in quality.

• Master of Science degree preferred.

• 5+ years of experience in a manufacturing environment preferred.

• Experience in medical device manufacturing preferred.

• Any Quality Certification is a plus.

Work Environment

The work environment involves a balance between time spent in engineering offices and being out on the floor with equipment and operators, providing a dynamic and hands-on experience.

Pay and Benefits

The pay range for this position is $90000.00 - $110000.00/yr.

- Vacation, holiday, sick pay

- Medical, dental, vision insurance

Workplace Type

This is a fully onsite position in Oregon City, OR.

Application Deadline

This position is anticipated to close on Aug 25, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actALENTaccommodation@actalentservices.com for other accommodation options.