Documentation Change Analyst II (Medtech)

TL;DR

Documentation Change Analyst II (PLM/Medtech): Supporting quality system documentation and the change control process for lifesaving medical products with an accent on ECO, ECR, and MCO processing. Focus on managing product lifecycle management (PLM) data, coordinating between engineering and manufacturing, and ensuring FDA cGMP compliance.

Location: Onsite in Chelmsford, MA

Salary: $25.70 - $38.60 per hour

Company

hirify.global is a global provider of innovative medical devices and software used worldwide to diagnose and treat critical cardiopulmonary and respiratory conditions.

What you will do

• Generate and process Engineering Change Orders (ECOs), Requests (ECRs), Manufacturing Change Orders (MCOs), and Process Deviation Authorizations (PDAs).
• Manage the creation of part and document numbers within the Product Lifecycle Management (PLM) system.
• Coordinate with all internal departments to ensure data integrity between PLM and Oracle Business systems.
• Analyze operational requirements by interviewing customers and project teams to document results and prepare system documentation.
• Act as a direct liaison to functional process owners to prioritize project requirements.
• Maintain and update the PLM working knowledge base in collaboration with the PLM Administrator.

Requirements

• Location: Must be based in Chelmsford, MA
• 3+ years of experience in Documentation Control.
• High School Graduate or equivalent (Associate's Degree preferred).
• Proficiency in Microsoft Office (Word, Excel) and Adobe Acrobat.
• Working knowledge of Bill of Material (BOM) structuring and part numbering.
• Understanding of FDA current good manufacturing practices (cGMP).

Nice to have

• Experience with Product Lifecycle Management (PLM) systems.
• Working knowledge of Oracle.

Culture & Benefits

• Purpose-driven work focused on improving patient outcomes and saving lives.
• Innovative and entrepreneurial culture within a fast-growing global company.
• Comprehensive benefits plans available to employees.
• Collaborative environment operating across more than 140 countries.