Technical Document Specialist

3 weeks ago

Santa Rosa, United States SMC Corporation Full time

Located in beautiful Santa Rosa, CA, SMC, Ltd. is a globally recognized premium supplier to the medical market with locations throughout the world. People committed to speed, technology, and exceptional performance are the cornerstone of our organization. Comprised of dedicated people and decades of manufacturing experience, we have continued to experience strong growth and currently have outstanding career opportunities for equally dedicated people.

In the role of a Set-up Technician, you will be responsible to perform other related duties in conjunction with other employees and departments contributing to the overall team effort, efficient process, and safe working environment. Assist the shift Supervisor, Manufacturing Associates, Production Planner and Engineers. Position includes many essential components necessary for successful and efficient manufacturing, and as such, shares full responsibility for the final product delivered to the customer.

In the position of a Technical Document Specialist, you will be responsible for managing and ensuring the accuracy of shipping certifications, quality records, and internal documentation. This role involves verifying compliance with customer and regulatory requirements, maintaining production binders, and coordinating essential quality processes. The Specialist plays a key role in troubleshooting traceability issues, and supporting the change control process.

Essential Job Duties and Responsibilities:

  • Prepare and verify all customer required shipping certifications and share them with customers (portal or email) as required.
  • File, scan and storage of electronic/hardcopy quality records and packing slips as per customer and/or regulatory requirements.
  • Review Contract Packets and confirm the inspection instructions are correct per P.O.’s and material is correct according to print.
  • Search and print vendor CoC as per customer requirements
  • Create, prepare, issue, maintain and update production binders
  • Create and update internal documents (procedures, work instructions, forms, shipping documentation, etc.) as needed.
  • Store records related to CAPAs, SCARs, CARs into the system. In addition to participating in their investigation process as required.
  • Troubleshoot material and product traceability issues as appropriate
  • Coordinate ECO process (Initiation up to release) as needed.
  • Maintain training database and scan all training records and work orders; build and maintain library for lot traceability.
  • Other duties as assigned
Essential Qualifications:
  • High School Diploma or equivalent.
  • Basic computer skills and office package (word, excel, PowerPoint, outlook) experience
  • Ability to read, write and communicate in English.
  • Adaptability to a dynamic work environment.
  • Teamwork and collaboration
  • Quality inspection experience
Desirable Qualifications:
  • Experience within the medical device industry
  • Experience in document control processes
  • Product release experience
ADA Requirements:
  • Typically sits, grasps items and performs keyboarding for frequent operation of a computer
  • Stand, walk, bend, reach or otherwise move about regularly
  • Lift, move, or otherwise transfer items up to 40 lbs. occasionally, >20 lbs. frequently
  • Occasional exposure to typical machine shop physical hazards

We are committed to fair and equitable hiring with salaries based on relevant factors, such as work experience, education, and certifications. Toward the principle of equal pay for equal work, we post and hire within defined salary ranges. We ask all applicants to review salary ranges for each posted job opportunity, as we will not hire outside the predetermined range.

Hourly Range $24.00 - $30.00 / hour

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