Roth Staffing · 1 week ago
Document/Change Control Analyst
Irvine, CA
Contract
Onsite
Senior Level
5+ years expRoth Staffing is seeking a Quality Systems Analyst to support corporate quality strategic initiatives by collaborating with business representatives to document requirements and processes. The role involves analyzing changes, managing documentation, and ensuring compliance with quality standards in a fast-paced environment.
Recruiting
Hiring Manager
Melanie Delaney
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
Able to multi-task and handle variable loads independently within multiple systems (Windchill PLM, JDE)
High attention to detail and robust understanding of document control and GDP
Proactive, quick learner with strong communication and decision-making skills
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)
Participate in special projects, complete assigned tasks and deliverables
Evaluate changes proposed by initiators and provide feedback
Other incidental duties assigned by Leadership
Works independently without close supervision
Compares and evaluates possible courses of action after considering various possibilities
Applies his or her knowledge in following procedures or in determining which procedures to follow or determining whether specified standards are met
Considers the cause and effect of activities
Determines or effectively recommends course of action after considering potential risks of alternatives
May provide guidance to lower level personnel
Makes 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
Direction tends to be high level and focused on end results with means of accomplishment left to incumbent
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 these 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
Qualification
Required
Change control/document control
Ability to think critically and problem solve on their own
Experience with PLM software (preferably Windchill)
Support corporate quality strategic initiatives
Work with business representatives to understand and document business requirements, processes and workflows
Develop both written and visual depictions of requirements and process flows
Partner effectively with all levels of the organization to drive results
Proactively identify and resolve problems and escalate as required
Work with IT to develop functional specifications
Act as Subject Matter Expert for proposed solutions
Work with the Corporate Quality PMO to ensure solutions are successfully developed, deployed and sustained
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
Able to multi-task and handle variable loads independently within multiple systems (Windchill PLM, JDE)
High attention to detail and robust understanding of document control and GDP
Proactive, quick learner with strong communication and decision-making skills
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)
Participate in special projects, complete assigned tasks and deliverables
Evaluate changes proposed by initiators and provide feedback
Work independently without close supervision
Compare and evaluate possible courses of action after considering various possibilities
Apply knowledge in following procedures or in determining which procedures to follow
Consider the cause and effect of activities
Determine or effectively recommend course of action after considering potential risks of alternatives
May provide guidance to lower level personnel
Make decisions in the face of different alternatives and without formulas or guidelines
Lead small scale projects where analysis of situations requires an in-depth evaluation of multiple factors
Drive to resolve issues completely and with speed by leveraging network of key contacts outside own area of expertise
Drive improvement of current practices and work with appropriate functions to implement changes or participate in their implementation
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 including negotiating and relationship management 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
Adhere to compliance with internal procedures
Bachelor's Degree or equivalent in related field of study
5-7 years of experience
Preferred
Knowledge of Windchill PLM
Company
Roth Staffing
Roth Staffing is a values-driven staffing firm, passionate about creating remarkable experiences every day and making life better for our customers, the temporary employees we place, our coworkers and our communities.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Adam Roth
CEO
Mimi Taylor
SVP & CFO
Recent News
2025-10-23
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