Sr Analyst, Quality Systems

4 hours ago

Irvine, California, United States Hydrogen Group Full time

Sr Analyst, Quality Systems

Irvine, CA

Schedule:
Standard Hours

Duration:
6-Month Contract

Pay:
$51-56/hr (W2)

Our client is a leading global medical technology company specializing in structural heart disease and critical care innovations. They are seeking a Senior Analyst, Quality Systems to support corporate quality strategic initiatives by partnering with business stakeholders to understand and document business requirements, processes, and workflows. This role will work closely with IT and the Corporate Quality PMO to develop, deploy, and sustain solutions in line with overall Corporate Quality objectives.

Essential Functions and 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
  • Support and process change packages against governing procedures, interact with departments to complete the change package, and release final change package
  • Perform incorporation of approved changes to documentation (e.g. JDE data entry and verify correct implementation)
  • Evaluate changes proposed by initiators and provide feedback
  • Develop both written and visual depictions of requirements and process flows
  • Work with IT to develop functional specifications and act as Subject Matter Expert for proposed solutions
  • Multi-task and handle variable loads independently within multiple systems (Windchill PLM, JDE)
  • Participate in special projects, complete assigned tasks and deliverables
  • 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 to resolve issues completely and with speed by leveraging your network of key contacts outside your own area of expertise
  • Drive improvement of current practices and work with the appropriate functions to implement changes or participate in their implementation
  • May provide guidance to lower level personnel
  • Make decisions in the face of different alternatives and without formulas or guidelines or with guidelines that are not complete and exhaustive, and which allow room for creativity and judgment

Education and Experience

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

Knowledge and Skills

  • Proven expertise in MS Office Suite
  • Knowledge of Windchill PLM preferred
  • Excellent written and verbal communication skills including negotiating and relationship management skills
  • Strong problem-solving and critical thinking skills
  • Good understanding of medical device documentation development activities
  • High attention to detail and robust understanding of document control and GDP
  • Ability to manage confidential information with discretion
  • Ability to manage competing priorities in a fast paced environment
  • Adhere to compliance with internal procedures

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