Configuration Control & Change Management Specialist II

CQ Medical•New Garden Township, PA

About The Position

CQ Medical is seeking a Configuration Control & Change Management Specialist II with hands-on experience in manufacturing ERP systems, bills of material (BOMs), routings, and product configuration management. The role maintains accurate product structures and controlled information, identifies and resolves data inconsistencies, and coordinates approved changes across manufacturing systems, documentation, and affected business processes. The specialist collaborates with Design and Manufacturing Engineering and coordinates with Engineering, Manufacturing, Quality, Regulatory Affairs, and other functions. The role also supports audits, change-record closure, process improvements, documentation development, and training of Configuration Control & Change Management Specialist I personnel. CQ Medical designs and manufactures radiation oncology medical devices for patient positioning, with the goal of improving the accuracy and comfort of cancer treatment.

Requirements

Bachelor's degree or equivalent experience in Business, Manufacturing, Engineering, Quality, Information Management, or a related discipline.
Minimum 3 years of relevant experience.
Strong understanding of controlled information and change implementation processes.
Ability to independently coordinate multiple change activities.
Strong understanding of data integrity and information accuracy principles.
Ability to identify, investigate, and resolve information discrepancies.
Strong organizational, prioritization, and follow-up skills.
Ability to communicate effectively with stakeholders across multiple functions.
Strong analytical and problem-solving capabilities.
Ability to work effectively with minimal supervision.
Ability to balance accuracy, timeliness, and business needs.

Nice To Haves

Experience with ERP, PLM, QMS, LMS, and document management systems.
Experience supporting engineering change, manufacturing change, or quality system change processes.
Experience developing work instructions, job aids, or process documentation.
Medical device or other regulated industry experience.

Responsibilities

Maintain complex product structures, bills of material, routings, and controlled information.
Verify the accuracy, completeness, and consistency of information before implementation.
Identify and resolve discrepancies across systems, records, and documentation.
Support audits and reviews related to product and process data integrity.
Coordinate implementation of approved changes across affected systems and records.
Ensure required actions, documentation, training assignments, and supporting activities are completed.
Monitor implementation status and follow up on outstanding actions.
Support successful completion and closure of change records.
Identify incomplete, inaccurate, or conflicting information; obtain missing information and resolve issues with stakeholders.
Recommend corrective actions to improve information quality and implementation effectiveness.
Support investigations of recurring implementation or data integrity issues.
Serve as a resource regarding change implementation requirements and processes.
Coordinate activities with Engineering, Manufacturing, Quality, Regulatory Affairs, and other business functions.
Support training of Configuration Control & Change Management Specialist I personnel.
Identify opportunities to improve the efficiency, accuracy, and effectiveness of change implementation processes.
Assist with developing work instructions, job aids, and process documentation.
Support process improvements and standardization efforts.