Shimadzu USA Manufacturing Inc
- Full Time
- M-F Onsite
- Canby, Oregon
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 over 20 years, Shimadzu is a stable company with a great crew and work environment.
We currently have an excellent opportunity for a Senior Document Control Specialist reporting directly to our Quality Manager. This position is responsible for preparation, documentation, and disbursement of controlled documents in accordance with Shimadzu’s policies, ISO 13485:2016 and FDA/QSR Standards. In this role, you will identify requirements for new or revised regulatory compliance procedures, while providing direction for the preparation and control of these documents.
The ideal candidate has strong organizational skills with solid knowledge and experience in an ISO setting (ISO 13485:2016 – preferred). A strong understanding of FDA/QSR, plus basic knowledge of RoHs regulations, will further your success in this role. This position also involves a high degree of complexity and critical thinking.
- Coordinates the release of engineering control notices (ECN’s) to the quality engineering team for review and implementation, to include input of ECN data into the master database.
- Validates the accuracy of production, engineering, and quality documents, including appropriate approvals.
- Distributes controlled documents, as required, and maintains filing system.
- Ensures most current revision level of documentation is available in controlled file locations, to include removal of obsolete documents.
- Identifies requirements for new or revised regulatory compliance procedures, including modifications to the Quality Manual, and provides direction for the preparation and control of these documents.
- Trains co-workers, as needed, on documentation procedures.
- Ensures documentation standards and procedures keep pace with current practices and business requirements.
- Manages all documents required for the internal ISO audit function.
- Interviews co-workers to gather information and data for internal ISO audits. Evaluates this information to identify corrective actions and/or training needs.
- Recommends improvements to internal audit methods to ensure quality system standards are maintained.
- Performs internal audits both annually and on an as needed basis.
- Writes internal ISO standard audit report for submittal to management.
- Acts as liaison to external ISO auditors during official audits.
- Assists with compliance with regulatory agencies (FDA, ISO, RoHs,) regarding documentation and quality.
- High School Diploma or equivalent – required
- 3 years’ general office experience – required
- 2 years computer experience utilizing MS Office applications – required
- Bachelor’s Degree in Engineering, Computers, Materials Management, or related field or equivalent – preferred
- 2 years’ experience in a manufacturing/assembly environment – preferred
- Certificate of ISO 9001:2008 (or ISO 13485:2016) standards of compliance auditor training – preferred
Health Insurance Benefits (starting 1st of the month)
Medical / Vision / Dental (with Orthodontia Option)
Life / AD&D / Short- & Long-Term Disability
Paid Time Off
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
Please email your resume to Siobhan Gardner, Sr. HR Generalist: Sgardner@Shimadzusum.com
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.