Quality Engineer - Change Control

Lumencor, Inc., based in Beaverton, Oregon, manufactures high-performance solid state lighting subsystems, "light engines," for bioanalytical instruments, medical devices and life science research tools. Products are sold worldwide to equipment manufacturers (OEMs), distributors, laboratories and individual researchers. The company is seeking a Quality Engineer to contribute to the production of Lumencor light engines and accessories.

Lumencor is seeking a quality engineer with experience in engineering change control, project management and stage gate development to join our team. This position will report to the Quality department and drive compliance with ISO 9001:2015 and customer change management requirements. This position will leverage project management techniques and skills to facilitate the Engineering Change Notice (ECN) process, owning the implementation of all engineering changes.

The successful candidate will also provide project management support to the NPI team to drive change control requirements and ensure successful transfer of new products to manufacturing.

• Manage all NPI, Manufacturing and Quality projects within the Engineering Change Notice process, driving the timely completion of tasks by cross functional team members.

• Communicate with subject matter experts to thoroughly document the critical project details and identify all of the required actions, responsibilities, and timing of tasks.

• Establish and maintain a thorough checklist of change control requirements to verify all critical tasks associated with the engineering changes are addressed.

• Coordinate disposition plans for existing inventory of the old revision of parts and assemblies and manage transition to prevent part shortages and line down situations.

• Monitor and assign resources appropriately to streamline engineering change orders to promote efficiency and consistency of outputs.

• Support specifications for copy exactly requirements and seek customer approval as needed to implement design changes.

• Create support documentation and records management to comply with ISO 9001 requirements.

• Perform training to ensure the team is familiar with and knowledgeable regarding engineering change management processes and procedures.

This role is an on-site, full-time, salaried position in which it is expected employee will report to work daily, during regular business hours to fulfill assigned work duties.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

• B.S. or M.S. degree in quality, manufacturing engineering or related technical field.

• Experience with ISO 9001 Quality Management Standard, knowledge of ISO 13485 preferred.

• Experience in project management and engineering change order processes.

• Demonstrated project management skills and experience leading projects through stage gates.

• Experience with new product introduction and product qualifications.

• Microsoft Teams and SharePoint collaboration skills preferred.

• Strong presentation and communication skills.

• Excellent analytical and problem-solving skills.
• Proactive, self-sufficient, creative and collaborative work style.

At Lumencor, our standards are high. Our Engineering team continually pushes to deliver the best lighting solutions the industry has ever seen. We do this by relying on the talent and ingenuity of our staff. We look for people who can think critically and creatively; people who can dream big and act responsibly as they push past boundaries in an ethical and collaborative manner. Lumencor found its beginnings in challenging the status quo by recognizing and executing on the very best of what is possible; this fundamental quality permeates through the culture of the company to this day.

If this describes the type of team you would like to be a part of, we want to speak with you!

Lumencor believes in a healthy work environment for all employees, and fosters teamwork and respect for others while adhering to ethical work practices. We offer a full package of employees health, dental and vision insurance as well as many other perks. Our working culture rewards effort and success while embracing imagination and diversity. We are an Equal Opportunity Employer.

Lumencor requires all current and future employees to be fully vaccinated for Covid-19 as a condition of hire unless they are eligible for accommodation under applicable law.