Actalent is currently accepting applications for a direct role with a client in the Portland Metro Area.
Job Description
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
CAPANew product introductionValidation (IQ/OQ/PQ)Quality engineeringISO standards and QMSRoot cause analysisMedical 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 quality5+ years of experience in a manufacturing environmentExperience 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.
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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.
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.