Change Management Analyst

Requirements

Must have:

– I seek a strong understanding of change order systems, particularly Agile and ideally Oracle PLM systems. – Familiarity with documentation control processes in a Quality Management System (QMS) is essential. – Knowledge of FDA Quality System Regulations and ISO 13485 standards is advantageous. – A basic understanding of material disposition and product-related change processes is important.

Responsibilities:

• In this Change Analyst 3 position, I will optimize our Documentation Control System. – I will facilitate and manage all change order activities in Agile, ensuring fluid transitions from initiation through to implementation. – I will also support ongoing improvement initiatives, assist with product changes, and play a crucial role in maintaining compliance with quality and regulatory standards.

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Company:

• I value individuals who thrive in detail-oriented environments and enjoy collaborating across teams. – I look for someone who is ready to take ownership of vital documentation processes. – I highly appreciate exceptional attention to detail along with data entry accuracy. – Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) is required. – I desire strong interpersonal and communication skills for training and collaborating within cross-functional teams. – The ability to manage and track multiple change orders from initiation to implementation is important. – I expect analytical skills and the capacity to use independent judgment to resolve problems and enhance processes. – Experience with Key Process Indicators (KPIs) and compiling status reports is a plus. – As for behaviors, I value being organized and having a proactive stance towards documentation and change order processes. – A mindset focused on continuous improvement, collaboration, adaptability, and accountability is crucial, as is a customer-service orientation that emphasizes training and educating others on best practices. – I prefer candidates with 4-6 years of experience in documentation control and/or managing change orders, preferably in a regulated industry such as medical devices. – Proven ability to manage change orders through their lifecycle, including approvals and implementations, is essential. – Experience in supporting audits (internal, external, or third-party) to demonstrate compliance with quality standards is required. – Hands-on experience in FDA- or ISO 13485-regulated industries is highly preferred, as well as familiarity with integrating new business, products, or NPI activities into existing systems. Why join us at Hologic? I am dedicated to making Hologic the premier destination for top talent. To ensure your success, I will provide you with the necessary tools and knowledge, including comprehensive training upon your arrival and continuous development throughout your career. The expected annual base salary for this role ranges from $57,100 to $85,600 and is eligible for bonuses. The final compensation packages will depend on various factors, including relevant experience, skills, knowledge, education, business needs, and market demand. I am proud to be an Equal Opportunity Employer, inclusive of individuals with disabilities and veterans.

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