Release Analyst

Job title : Release Analyst


Client : Medical Device Manufacturing Company


Duration : 12 Months (Possibility of Extension)


Location : Fridley, MN 55432


Shift : 1st Shift

Job Description:


The Release Analyst supports product release activities, configuration management, and quality systems documentation for labeling and packaging components. This role ensures compliance with regulatory standards while managing documentation, eManual releases, and product lifecycle processes.

Key Responsibilities:


Configuration Management:
• Prepare and route Change Notifications (CNs)
• Review components and specifications before release
• Maintain product models and finished goods in PLM systems
• Fulfill requests for electronic labeling documentation


Quality Systems:
• Prepare and route product design documentation
• Perform audits and proofing of labeling and packaging components
• Ensure compliance with quality policies and procedures
• Validate vendor labeling and documentation accuracy


eManuals Release:
• Manage release of manuals on eManuals platforms
• Configure attributes and ensure content accuracy
• Support product launches with manual releases
• Participate in UAT testing and feature enhancements
• Troubleshoot content, quality, and release issues


Product Release & Process Improvement:
• Verify UDI (Unique Device Identification) requirements
• Support Device Master Record (DMR) indexing
• Analyze and improve processes using data-driven methods
• Develop and track process metrics and KPIs
• Identify root causes and implement improvements
• Participate in Lean/Six Sigma initiatives

Required Qualifications:
• Bachelor's degree with 2+ years of experience OR Master's with 6+ months experience
• Strong attention to detail and organizational skills
• Ability to multitask and manage shifting priorities
• Proficiency in MS Office (Word, Excel, Adobe)
• Ability to learn and adapt to new systems and tools
• Strong communication and teamwork skills

Preferred Qualifications:
• Experience in medical device or regulated environments
• Knowledge of FDA, ISO, EN, or GMP standards
• Experience with PLM systems and configuration management
• Exposure to labeling, packaging, or documentation processes

Core Competencies:
• Configuration & Change Management
• Quality Systems & Compliance
• Process Improvement (Lean / Six Sigma)
• Data Analysis & Root Cause Identification
• Cross-Functional Collaboration
• Documentation & Regulatory Standards

Role Characteristics:
• Individual contributor role with moderate supervision
• Handles moderately complex projects and assignments
• Supports cross-functional teams and stakeholders
• May mentor junior team members


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