Job Title: Quality Engineer
Location: Wilsonville, OR
Job Type: Regular
DWFritz Automation, founded in 1973, has experienced rapid growth over the last 5 years and continues to grow! Since its inception, DWFritz has been producing brilliant automation solutions for our clients. Today, the market demand for automation combined with our world-class practices and cutting-edge technology places DWFritz on a trajectory to becoming a leading provider in the field of automation.
One thing that hasn’t changed at DWFritz is our focus on our core values, such as “Collaborate and Share the Credit,” a value that is deeply engrained in how we work together both in our US and China facilities. Our core value “Find a Better Way” promotes innovation and openness to doing things differently. It’s also the reason we have a company supported incubator program and an in-house lab.
Our World Headquarters operates from a modern, state-of-the-art facility located in Wilsonville, Oregon. Our employees enjoy standing desks, a recreation room, a fitness room, and a hearty oatmeal breakfast to start each day. Our spacious lunch room is the venue for weekly All Staff meetings and our frequent “Lunch and Learns.”
DWFritz is a wonderful place to work, with unique opportunities to participate in dynamic teams, a strong sense of culture and values, and a growing company. If you are considering a new opportunity we encourage you to check us out.
Your Operations Team at DWFritz
Operations at DWFritz is a multi-functional team driven to deliver world class performance at an expeditious pace, with an ingrained culture of continuous improvement. This team works side by side with all the other functional team members at DWFritz, to deliver world class, high precision automated tools for a very dynamic and diverse top tier customer base, covering multiple industries. The team members work in a very collaborative environment, and are focused on doing what is needed to meet the customer’s needs on time and budget. The environment thrives on an Integrated Product Team culture, addressing dynamic challenges with tactical execution and strategic planning, always focused on finding opportunities for improving operations, finding a better way, and exceeding our customer’s expectations.
The Quality Engineer is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. The position is responsible for the development, implementation, improvement and continuous reinforcement of established Quality fundamental practices that are utilized in the local business.
Responsible for ensuring regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.
Responsible for the development, implementation and continuous improvement of process effectiveness and efficiency at the site.
Develops process improvement plans using a variety of Quality and Continuous Process Improvement tools, including but not limited to Six Sigma, Lean Manufacturing, 5S, SPC, engineering studies, DOE, Gauge R&R, etc.
Ensures process efficiency and compliance effectiveness through the development and implementation of process verification and validation plans, including Master Validation Plans (Site Level), Validation Master Plans (Product or Process specific plans), and the development of simple yet detailed process flow diagrams that describe critical process interdependencies with respect to process inputs, outputs, risks and impacts.
Supports continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective action and improvement programs.
Develops risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc. Supports design mitigation efforts. Develops process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process.
Ensures process compliance through the development of simple yet comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.
Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.
Demonstrated understanding or aptitude to understand ISO quality management system requirements and regulatory requirements.
Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing in a medical device environment.
Demonstrated experience using word processing, spreadsheet, and presentation software.
Demonstrated understanding of continuous quality / process improvement tools: (As defined by the local site, e.g. DMAIC, SPC, Lean SS, 5S,)
Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes
Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production &process controls; Corrective Action & improvement, complaints & risk management; & product quality improvement
Demonstrated collaboration, negotiation & conflict resolution skills
Excellent oral communication & report, business correspondence & procedure-writing skills
Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance
Change agent with energy, passion & enthusiasm to drive change
Exceptional analytical, problem solving & root-cause analysis skills
Ability to multi-task & handle tasks with competing priorities effectively
Integrity: Accepting & adhering to high ethical, moral & personal values in decisions, communications, actions & when dealing with others
Understanding customer needs, marketplace dynamics, industry trends, & the competitive landscape in the industry/function & considering the external impact of business activities & decisions on the external environment
Energizing others by building a connection with the team through personal involvement & trust & providing feedback & coaching to help develop others
Simplifying strategy into specific actions with clear accountability, making decisions with speed & accuracy based on best available information & communicating priorities clearly & concisely
Your Education and Experience
Bachelor’s degree (with experience in Process Engineering, Quality Engineering or Quality Assurance Management)
Five or more years exposure to multiple engineering disciplines preferred