Sr. Quality Systems Analyst

About This Role

Support corporate quality strategic initiatives by collaborating with business representatives to understand and document business requirements, processes, and workflows, while partnering with IT to develop functional specifications and act as a Subject Matter Expert for proposed solutions.

Responsibilities

• Analyze varying complexity of changes and resolve issues with collaboration from cross-functional departments
• Understand Product Lifecycle Management, ERP, and other Change Control processes and relationships
• Multi-task and handle variable loads independently within multiple systems (Windchill PLM, JDE)
• Support and process change packages against governing procedures, interacting with departments to complete and release final change packages
• Perform incorporation of approved changes to documentation (e.g., JDE data entry and verify correct implementation)
• Participate in special projects, completing assigned tasks and deliverables
• Evaluate changes proposed by initiators and provide feedback
• Lead small-scale projects where analysis of situations requires an in-depth evaluation of multiple factors and/or requires an in-depth knowledge of organizational objectives
• Drive improvement of current practices and work with appropriate functions to implement changes or participate in their implementation

Requirements

• 5-7 years of experience in a quality and/or manufacturing environment in the medical device industry
• Proven expertise in MS Office Suite
• Excellent written and verbal communication skills
• Strong problem-solving and critical thinking skills
• Good understanding of medical device documentation development activities
• Ability to manage confidential information with discretion
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast-paced environment
• Adherence to compliance with internal procedures

Qualifications

• Bachelor's Degree or equivalent in related field of study
• 5-7 years of experience in a quality and/or manufacturing environment in the medical device industry required

Nice to Have

• Knowledge of Windchill PLM

Skills

* Required skills