Hologic, Inc. · 4 months ago
Change Analyst 3
Louisville, CO, United States
Full-time
Onsite
Mid Level
$57K/yr - $86K/yr
4+ years expHologic, Inc. is seeking a Change Analyst 3 to optimize their Documentation Control System. In this role, you will facilitate and manage change order activities, support continuous improvement initiatives, and ensure compliance with quality and regulatory standards.
BiotechnologyHealth CareHealth DiagnosticsWomen's
Responsibilities
Facilitate and manage all change order activities in Agile, ensuring smooth transitions from initiation to implementation
Support continuous improvement initiatives
Assist with product changes
Play a critical role in maintaining compliance with quality and regulatory standards
Qualification
Required
Bachelor's Level Degree
Strong understanding of change order systems, including Agile and Oracle PLM systems
Knowledge of documentation control processes within a Quality Management System (QMS)
Familiarity with FDA Quality System Regulations and ISO 13485 standards
Basic understanding of material disposition and product-related change processes
Exceptional attention to detail and data entry accuracy
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
Strong interpersonal and communication skills to train and collaborate with cross-functional teams
Ability to manage and track multiple change orders from initiation to implementation
Analytical skills with the ability to use independent judgment to solve problems and optimize processes
Experience with Key Process Indicators (KPIs) and publishing status reports
Highly organized with a proactive approach to managing documentation and change order processes
A continuous improvement mindset, actively seeking opportunities to streamline and optimize workflows
Collaborative and adaptable, with a focus on supporting team members and business needs
Accountability and ownership in ensuring compliance and quality standards are met
Customer-service oriented with a focus on training and educating others on best practices
4-6 years of experience in documentation control and/or managing change orders, preferably within a regulated industry (e.g., medical devices)
Proven ability to manage change orders across their lifecycle, including approvals and implementation
Experience supporting internal, external, or third-party audits to demonstrate compliance with quality standards
Hands-on experience in industries regulated by FDA or ISO 13485
Familiarity with integrating new business, products, or NPI activities into existing systems
Preferred
Strong understanding of change order systems, including Agile and Oracle PLM systems
Familiarity with FDA Quality System Regulations and ISO 13485 standards
Hands-on experience in industries regulated by FDA or ISO 13485
Benefits
Comprehensive training when you join as well as continued development and training throughout your career.
Company
Hologic, Inc.
We’re an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day.
5001-10000 employees
H1B Sponsorship
Hologic, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (31)
2024 (20)
2023 (15)
2022 (32)
2021 (20)
2020 (14)
Funding
Current Stage
Public CompanyTotal Funding
$2.87B2025-10-21Private Equity
2025-10-21Acquired
2025-07-15Post Ipo Debt· $2.42B
Leadership Team
Stephen MacMillan
Chairman President & CEO
Karen Harrington
Director Scientific Affairs
Recent News
2026-01-08
Company data provided by crunchbase