As a subsidiary of Shimadzu Japan, Shimadzu USA Manufacturing is a world leading manufacturer of scientific analytical instruments. Located in Canby, Oregon, our facility is an easy commute, just 7 miles south of Oregon City, and 12 miles north of Woodburn. In business for 25 years, Shimadzu is a stable company with a great crew and work environment.

Position Summary

We currently have an excellent opportunity for a Quality Engineer to join our Quality Assurance team. In this role, you will support the manufacture, inspection and test of world class medical devices in compliance with ISO 13485 and FDA QSR, while driving the execution of quality goals and objectives. The QE collaborates with Production, Engineering and Supply Chain to identify causes of potential product failures and to drive both corrective and preventative actions internally and with suppliers. The ideal candidate has a passion for meeting production, quality, and safety standards and a working knowledge of manufacturing principles and processes.

Essential Responsibilities

• Supports the Quality Manager in maintenance and continuous improvement of the QMS, to include training of personnel.
• Creates QMS documentation, to include development of standard operating procedures in support of the QMS.
• Supports or leads all areas of risk analysis, root cause investigation, and corrective and preventative actions.
• Manages all receiving, in process and out of box inspections, to include resolution of supplier caused non-conformances.
• Performs quality system audits at supplier locations.
• Optimizes the non-conformance handling process to minimize the duration of material quarantines.
• Own tasks associated with CAPA program and brings them to resolution.
• Participates in the regulatory functions related to RoHs, Conflict Mineral Reporting, and REACH.
• Works with cross-functional teams to resolve production and quality issues, with particular focus on continuous improvement.
• Performs internal quality audits and reviews, evaluating data and compiling results for management review.
• Monitors engineering production processes and products for adherence to internal quality requirements and standards.
• Qualifications
• Bachelor’s degree in Electrical, Mechanical or Chemical Engineering , or related fieldExperience in a Quality Engineering role

• Experience in a manufacturing/electronic assembly environment
• ISO / FDA experience – a plus

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.

Job Type: Full-time

Pay: $75,000.00 - $95,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Professional development assistance
• Referral program
• Retirement plan
• Tuition reimbursement
• Vision insurance

Schedule:

• Monday to Friday

Supplemental pay types:

• Bonus pay

Education:

• Bachelor's (Required)

Experience:

• Quality Engineering: 2 years (Required)

Work Location: One location

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