Configuration Control & Change Management Specialist II

CQ Medical Careers•Avondale, 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 complex product structures, BOMs, routings, and controlled information, ensuring that data is accurate, complete, and consistent before implementation. The specialist identifies gaps and discrepancies, collaborates with Design and Manufacturing Engineering to resolve them, and helps establish and reinforce effective configuration management practices. The position supports the broader change management process by coordinating the implementation of approved changes across manufacturing systems, controlled documentation, and affected business processes. It includes verifying implementation requirements, following up on outstanding actions, supporting change-record closure, contributing to audits and data-integrity reviews, and helping improve change implementation processes. The specialist also coordinates with Engineering, Manufacturing, Quality, Regulatory Affairs, and other functions, and supports training for Configuration Control & Change Management Specialist I personnel.

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 information accuracy, completeness, and consistency 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.
Work with stakeholders to obtain missing information and resolve incomplete, inaccurate, or conflicting information.
Recommend corrective actions to improve information quality and implementation effectiveness.
Support investigation of recurring implementation or data-integrity issues.
Serve as a resource on 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.