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

• 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.

Qualifications

• 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.

A Nissha Medical Technologies company, Isometric creates world-class micro components and assemblies for the medical and drug delivery markets.  To ensure our customers receive unparalleled micro solutions, we are passionate about acquiring and developing the brightest talent.  We are the largest medical-focused micro molder in the United States and proudly serve numerous medical device industries.  Join a team that was voted 2022 Large Business of the Year n St. Croix County and New Richmond, Wisconsin.

Day Shift Mon-Fri

Isometric is an Equal Opportunity Employer