Quality | Beaverton, OR | Full Time
Lumencor, Inc., based in Beaverton, Oregon, manufactures high-performance solid state lighting subsystems, "light engines," for bio-analytical instruments, medical devices and life science research tools. Products are sold worldwide to equipment manufacturers (OEMs), distributors, laboratories, and individual researchers.
Quality manager will oversee and coordinate all efforts related to quality and the ISO 9001 Quality Management System. Including, but not limited to managing corporate relations with ISO/quality bodies and quality standards/requirements of suppliers and customers.
You must feel comfortable working in a small-to-mid size organization with a fast paced atmosphere. Our employees wear multiple hats and do not shy away from needful tactical tasks.
- Manage, and support Lumencor’s Quality Management System and the ISO 9001:2015 Certification
- Maintain and administer key QMS subsystems, including design/change control, risk management, and validation (equipment, process, software, etc.)
- Act as the management representative, and host all external quality audits
- Oversee all internal audits and assemble audit teams
- Conduct periodic design reviews and design control meetings
- Work directly with Engineering, NPI, and Marketing to ensure all design/change control requirements are being met
- Lead/assist in creating DFMEAs and PFMEAs
- Responsible for working with Engineering and Manufacturing to develop validation protocols for production processes and generating reports covering the validation results
- Oversee the Change Control Process and develop necessary resources as needed
- Responsible for overseeing the quality aspects of Design Files and History Records
- Responsible for overseeing design control and supplier quality management activities
- Oversee and conduct supplier audits with assistance from material management
- Create procedures, validation protocols, and reports
- Implement a working system to ensure conformity and accuracy in the production process
- Represent quality on multi-discipline teams
- Collect and summarize items for management review and coordinate meetings as needed
- Oversee the CAPA process, SCARs, MRB, etc.
- Responsible for oversight and support of the customer complaint system and coordinating efforts with the Technical Support department
- Provide and oversee all applicable training as needed
- Ensure ongoing development and improvement of the QMS
- Manage all Quality and QA staff
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.
- A 4-year Bachelors Degree from an accredited university in a science, manufacturing, quality, or engineering discipline or equivalent work experience
- A minimum of 6-years experience managing a certified ISO 9001:2015 Quality Management System
- 4-years of Quality Engineering experience
- Direct experience implementing and maintaining QMS subsystems
- Experience with BOM structure and maintenance
- Experience with product structure and configuration management
- Experience working in a fast-paced technical environment, requiring multitasking, detail oriented work with minimal supervision
- Experience hosting quality audits for ISO certification
- CQA, CQE, and CQM certifications
- Experience with ISO13485:2016 with knowledge of 21 CFR part 820
- Experience with Apple/Macintosh computers
At Lumencor, our standards are high. We continually push to deliver the best microscopy lighting solutions the industry has ever seen. We do this by relying on the talent and ingenuity of our staff. Our Materials Management team are industry professionals who understand their professional efforts result in success for their team and the company. 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 apart 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.