Document Control & QMS Training Specialist
Summary
Title: | Document Control & QMS Training Specialist |
---|---|
ID: | 2454 |
Department: | Quality |
Location: | New Richmond, WI |
Description
The Document Control and QMS Training Specialist is responsible for maintaining manufacturing documentation within the company and ensuring document accuracy, quality, and integrity. The position is a mixture of data interpretation, data entry and documentation creation. Must be able to work with minimal supervision in a team environment and utilize problem solving skills, excellent organization, project management and time management skills to manage document control and processing for the organization.
Responsibilities
Day Shift Mon-Fri
Isometric is an Equal Opportunity Employer
Responsibilities
- Responsible for implementation, distribution and maintaining document control processes.
- Implement the change order review process and establish appropriate levels of approval.
- Add new users an maintain current user accounts.
- Work with management of supporting departments to determine/maintain appropriate training requirements.
- Establish and maintain record retention requirements according to internal, customer, and regulatory requirements.
- Maintain confidentiality regarding sensitive documents and records.
- Distribute documents as needed
- Draft written content and plan, review and revise content of project and company related documents and verify facts using standard references sources.
- Facilitate QMS training for new employees and refresher training for existing employees.
- Support audits and annual certifications by providing appropriate training documentation and responding to auditor requests.
- Review, scan, organize, store, manage, distribute, and track company documents.
- Maintain documents adhering to the company's document lifecycle procedures.
- Responsible for archive of inactive records in accordance with the records retention procedures.
- Support continuous improvement initiatives to simplify, streamline, and enhance document maintenance.
- Assists with file migrations, audits, and performs administrative tasks as needed.
- Assist with internal document routing and approvals.
- Review production documentation for accuracy.
- Ability to observe processes and document them.
- Associate degree or its equivalent and 3-5 years of related experience
- Must have knowledge of ISO13485 standards
- Proficient in navigating Microsoft Office Suite products
- Computer literate and adept at learning new systems
- Self-directed project management skills
- Exceptional writing and editing skills
- Strong interpersonal skills
- Very organized, detailed, and task oriented
- Excellent written and verbal communication skills.
Day Shift Mon-Fri
Isometric is an Equal Opportunity Employer
This opening is closed and is no longer accepting applications