• Change Analyst 3

    Hologic (Louisville, CO)


    Change Analyst 3

     

    Louisville, CO, United States

     

    Are you passionate about ensuring operational excellence within a Quality Management System? At Hologic, we are seeking a Change Analyst 3 to optimize our Documentation Control System. In this role, you’ll facilitate and manage all change order activities in Agile, ensuring smooth transitions from initiation to implementation. You’ll also support continuous improvement initiatives, assist with product changes, and play a critical role in maintaining compliance with quality and regulatory standards. If you thrive in a detail-oriented environment, enjoy collaborating across teams, and are ready to take ownership of key documentation processes, we’d love for you to join our team!

    Knowledge:

    + Strong understanding of change order systems, including Agile and Oracle PLM systems (preferred).

    + Knowledge of documentation control processes within a Quality Management System (QMS).

    + Familiarity with FDA Quality System Regulations and ISO 13485 standards is a plus.

    + Basic understanding of material disposition and product-related change processes.

    Skills:

    + 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.

    Behaviors:

    + 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.

    Experience:

    + 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 is highly preferred.

    + Familiarity with integrating new business, products, or NPI activities into existing systems.

     

    Why join Hologic?

     

    We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

     

    The annualized base salary range for this role is $57,100-$85,600 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.

     

    Agency and Third-Party Recruiter Notice

     

    _Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered._

     

    _Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans._

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