Quality Specialist

Fortive

1d • Hybrid

About The Position

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.

Requirements

• 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

Nice To Haves

• Prior experience with working on paper based QMS system is highly preferred.
• Health Physics background is highly preferred.

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.

Benefits

• Fluke Health Solutions offers competitive salary, time off, and benefits.
• Our offering includes PTO, paid holidays, medical/dental/vision on Day 1 + many more.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees