Infosoft, Inc. · 16 hours ago
Sr Engineering Change Control Analyst
Irvine, CA
Contract
Onsite
Senior Level
$63.14/hr - $63.14/hr
5+ years expInfosoft, Inc. is a Global medical device Manufacturer, and they are seeking a Sr Engineering Change Control Analyst to support medical device design, manufacturing, and quality assurance processes. The role involves analyzing changes, collaborating with cross-functional teams, and ensuring compliance with change control procedures.
ConsultingDeliveryHuman ResourcesInformation Technology
Hiring Manager
Riya Singh
Responsibilities
Analyze the 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 multitask and handle variable loads independently within multiple systems (Windchill PLM, JDE)
Close attention to detail and a 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 the final change package
Perform the 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 a course of action after considering the 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 the 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
Experience in engineering change control processes and documentation
Experience working with engineering/manufacturing information, including BOMs, Drawings, and manufacturing processes
Experience in a quality and/or manufacturing environment in the medical device or the pharma industry is required
5-7 years of experience required
Bachelor's Degree or equivalent in a related field of study
Experience in a quality and/or manufacturing environment in the medical device industry is 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
Preferred
Experience working with a PLM system; Windchill experience is preferred
Knowledge of Windchill PLM preferred
Company
Infosoft, Inc.
Infosoft is an HR services company focused on recruiting talent and building teams throughout the US market.
201-500 employees
H1B Sponsorship
Infosoft, Inc. has a track record of offering H1B sponsorships. Please note that this does not
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2025 (17)
2024 (37)
2023 (10)
2022 (14)
2021 (19)
2020 (23)
Funding
Current Stage
Growth StageCompany data provided by crunchbase