Quality Specialist

Location: Glenwood, IL (Hybrid)

As a Quality Specialist on our Fluke Health Solutions Quality Assurance team, you will play a critical role in maintaining compliance with ISO 17025, NQA‑1, 10CFR 50 Appendix B, ISO 9001 and other applicable regulatory standards. We are seeking a highly organized and detail‑oriented professional to oversee the creation, revision, distribution, and archival of controlled documents across the organization. The Document Control Specialist will be responsible for managing document workflows, ensuring proper configuration control, supporting audits, maintaining training and quality records, and partnering with cross‑functional teams to uphold documentation accuracy, accessibility, and regulatory compliance.

Responsibilities: 

• Maintain and administer the document control system, including procedures, forms, training and records for Glenwood and Solon site.
• Ensure proper document formatting, version control, and approval routing.
• Manage document distribution and ensure accessibility to authorized personnel.
• Oversee archival, retention, and secure storage of controlled documents.
• Support external audits by retrieving and organizing required documentation.
• Lead and support internal audits against ISO 17025 and ISO 9001 requirements. 
• Managing paper-based Quality Management Systems (QMS) and eQMS. 
• Maintain training documentation, including training records and qualification matrices.
• Monitor document lifecycle activities and ensure timely updates.
• Provide guidance to document owners on document creation and revision best practices.
• Coordinate change control documentation and ensure alignment with approved changes.
•  Ensure compliance with ISO 17025, NQA‑1, 10CFR 50 Appendix B, ISO 9001, and internal quality standards.
• Assist with NCR/CAPA documentation and quality system record management.
• Generate, compile reports and metrics for management reviews for both sites.
• Support continuous improvement initiatives related to documentation processes.
• Train employees in document control procedures and QMS usage. 

Qualifications:

• BA/BS in Engineering or physical sciences preferred. Equivalent experience, and/or ASQ certifications accepted.
• 3+ years of experience in a Quality Specialist role within a manufacturing environment.
• Strong problem-solving skills and experience with problem-solving tools.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Strong attention to detail and organizational skills.
• Proficiency in Microsoft Office Suite and Quality Management Software.
• Must have knowledge of the, ISO 17025, ISO 9001:2015, and/or NQA1 standards
• Prior experience with working on paper based QMS system is highly preferred.

• Health Physics background is highly preferred.

  
  
  

Your primary contacts will be:

Internal: Quality Assurance and Regulatory Affairs team, Operations team, Engineering team, Business Units as well as all other functional team members.

External: Industry peers, Regulatory agencies, Customers, Notified Body, Suppliers.

This is a full-time, hybrid position based in Glenwood, IL.  Fluke Health Solutions offers competitive salary, time off, and benefits. Our offering includes PTO, paid holidays, medical/dental/vision on Day 1 + many more. We want you to bring your whole self to FHS!

Fortive Corporation Overview

Fortive’s essential technology makes the world stronger, safer, and smarter. We accelerate transformation across a broad range of applications including environmental, health and safety compliance, industrial condition monitoring, next-generation product design, and healthcare safety solutions.

We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in software-powered workflow solutions, data-driven intelligence, AI-powered automation, and other disruptive technologies. We’re a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to groundbreaking sustainability solutions.

We are a diverse team 18,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact. 

At Fortive, we believe in you. We believe in your potential—your ability to learn, grow, and make a difference. 

At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone. 

At Fortive, we believe in growth. We’re honest about what’s working and what isn’t, and we never stop improving and innovating.

Fortive: For you, for us, for growth.