Senior Quality Engineer

Senior Quality Engineer

Actalent is currently accepting applications for a direct role with a client in the Portland Metro Area.

This Senior Quality Engineer is responsible for maintaining and enhancing product quality by fostering strong relationships with critical customers and collaborating with project management and manufacturing engineers. This role supports new product introductions, ongoing validation, and plans and executes 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.
• Serve as a customer liaison, processing customer quality complaints.
• Collect, analyze, and present data using statistical methodology.
• Assist suppliers with interpreting quality requirements.
• Contribute to 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, 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, including identification of key characteristics, associated sampling plans, and required gauging.
• Interface with appropriate customer contacts to clarify customer requirements.
• 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.
• Evaluate quality requirements on drawings, 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.
• Collaborate 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, reinforcing safety expectations and ensuring safety operating practices are demonstrated.
• Support quality and compliance by adhering to all procedures, work instructions, and forms per the Quality Management Systems (QMS).

Essential Skills

• CAPA
• New product introduction
• Validation (IQ/OQ/PQ)
• Quality engineering
• ISO standards and QMS
• Root cause analysis
• Medical device experience (other tightly regulated industries may be considered)

Additional Skills & Qualifications

• Bachelor of Science (Engineering ideally; others such as Business may be given consideration)
• 5+ years of experience in quality
• 5+ years of experience in a manufacturing environment
• Experience in medical device manufacturing (preferred)
• Any Quality Certification (preferred)

Work Environment

The work environment involves a combination of time spent in engineering offices and being out on the floor with equipment and operators. This dynamic setting offers the opportunity to directly engage with both the technical and practical aspects of quality engineering.

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 Gladstone, OR.

Application Deadline

This position is anticipated to close on Sep 27, 2025.