As a subsidiary of Shimadzu Japan, Shimadzu USA Manufacturing is a world leading manufacturer of scientific analytical instruments, primarily for the medical community. We are located in Canby, Oregon so our facility is an easy commute, just 7 miles south of Oregon City, and 12 miles north of Woodburn. Shimadzu has been in business for over 25 years, is a stable company with a great values and work environment. Come join our continued success.

Position Summary

We currently have a new opportunity for a Technical Documentation Specialist. This position will be responsible for the administration of the Engineering Change Notification (ECN) operational process by working with all departments to meet targeted completion dates, budget, cost, and quality objectives along with ECN meetings and ensures ECNs are implemented as scheduled. This position is also responsible for updating controlled documentation as records (for closed ECN’s), and the maintenance of controlled documentation through electronic documentation logs. If you thrive in a fast paced and challenging environment, then we want to hear from you!

Essential Functions:

• Administers ECN project plans focusing on target completion dates, budgeting, cost and quality considerations.
• To ensure successful implementation, collaborates with the ECN Coordinator on modifications to the ECN process, as needed, during the project.
• Works with ECN and Quality team to understand the scope of the ECNs in the Operational path.
• Participates in projects to resolve problems and to support continued process improvement through ECNs.
• Compiles product and parts specifications for various departmental uses.
• Coordinates the modification of documents with Engineering, Document Control and production staff to ensure compliance to documentation policies and procedures. This includes validating the accuracy and integrity of documents and production files.
• Reports project progress and timely distributes new and revised documentation related to ECN’s and other technical information to the appropriate personnel.
• Assists in preparation, documentation, and dissemination of controlled documents in accordance with Shimadzu ECN policies.
• Assists in the management of documents required for compliance to ISO 13485:2016 standards and company polices.
• Prepares documents for long-term storage.
• Ensures most current revision level of documentation is available in controlled file locations and that obsolete documentation is removed.

Secondary Functions:

• Performs duties in support of the company’s quality policy and ISO 13458:2016 and FDA/QSR.
• Maintains a safe and clean work environment.
• Performs other duties as assigned.

Education & Experience:

• High School diploma or equivalent.
• Associate’s Degree required or 2 years’ experience in manufacturing with experience in ECN and/or Documentation Control.
• 1 year experience in Manufacturing experience as it relates to ECN process and/or Documentation control.
• Experience with ISO Quality Management System - preferred

Benefits:

• Health Insurance Benefits - Medical / Dental / Vision (starting 1st of the month)
• Life / AD&D / Short- & Long-Term Disability
• Paid Leave (including 10 paid holidays, bereavement, jury duty)
• 401(k) Retirement Plan with company matching contributions
• Flexible Spending Accounts
• Employee Assistance Program
• Tuition Reimbursement Program

A Background Check and Drug Screen for the illegal use of drugs is required.

We are committed to the principle of equal opportunity employment for all candidates and employees, and to providing a work environment free of discrimination and harassment. All qualified applicants will receive consideration for employment without regard to age, race, national origin, color, religion, sexual orientation, gender identity, veteran status and/or disability