Are you passionate about maintaining quality systems and driving process improvements? Hologic is looking for a Change Analyst 2 to ensure seamless change order processes and uphold the highest standards in our quality management systems. If you’re detail-oriented, tech-savvy, and thrive in a collaborative environment, this role is perfect for you!
Knowledge:
- Are you passionate about maintaining quality systems and driving process improvements? Hologic is looking for a Change Analyst 2 to ensure seamless change order processes and uphold the highest standards in our quality management systems. If you’re detail-oriented, tech-savvy, and thrive in a collaborative environment, this role is perfect for you!
Comprehensive understanding of quality management systems, change order processes, and regulatory standards (FDA QSR, ISO 13485). - Familiarity with document control systems, particularly Agile and Oracle, is preferred.
- Knowledge of continuous improvement techniques and process optimization strategies.
- Expertise in managing and coordinating change orders from initiation to implementation, including material disposition and follow-up actions.
- Awareness of key process indicators for document control and the ability to generate status reports.
Skills:
- Strong attention to detail and data entry accuracy to ensure all change orders meet compliance standards.
- Advanced proficiency in MS Office tools (Word, Excel, PowerPoint) for documentation, reporting, and training materials.
- Strong interpersonal and communication skills to train users, collaborate with cross-functional teams, and provide guidance on change order processes.
- Ability to lead and execute continuous improvement projects to optimize document control processes.
- Analytical mindset with the ability to exercise independent judgment, evaluate processes, and propose solutions.
Behaviors:
- Highly organized and methodical, ensuring change orders are processed efficiently and accurately.
- Proactive and solution-driven, committed to continuous improvement and compliance.
- Collaborative team player with a strong sense of accountability and ownership over projects.
- Resilient and adaptable in managing multiple priorities and deadlines in a fast-paced environment.
- Detail-oriented, ensuring compliance with documented quality system requirements and regulatory standards.
Experience:
- 3–5 years of experience in document control and change order processes, preferably in the medical device industry.
- Hands-on experience in industries regulated by FDA Quality System Regulations or ISO 13485.
- Proven track record of facilitating change orders and supporting quality management systems from initiation to implementation.
- Experience in training users on systems and processes, including integration of new business/products and NPI activity.
- Demonstrated success in leading or contributing to process improvement initiatives.
The individual fulfilling this role must possess the physical capability to sit for extended periods, handle, or manipulate objects, tools, or controls with precision. Additionally, they should be able to stand, walk, reach with hands and arms, stoop, kneel, crouch, and be prepared to engage in domestic and international travel as required by the position.
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 $50,000-$74,900 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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