Ledgent Technology · 6 days ago
Document/Change Control Analyst
Irvine, CA
Full-time
Onsite
Senior Level
5+ years expLedgent Technology is seeking a Document/Change Control Analyst to work onsite in Irvine, CA. The role involves supporting corporate quality strategic initiatives by documenting business requirements and processes, collaborating with various departments, and ensuring compliance with quality objectives.
Staffing & 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 in a quality and/or manufacturing environment in the medical device industry required
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 required
Preferred
PLM software (Windchill preferred)
Knowledge of Windchill PLM preferred
Company
Ledgent Technology
Ledgent Technology, a business line of Roth Staffing Companies, utilizes proven processes and their robust professional network to place qualified technology professionals in contract, contract-to-hire, direct-hire roles and project teams throughout the US.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase