Configuration Control & Change Management Specialist II

CQ Medical•New Garden Township, PA

11d

About The Position

This role serves as a primary resource for change implementation activities and is responsible for identifying information gaps, resolving discrepancies, coordinating stakeholders, and ensuring approved changes are implemented accurately and completely. The Configuration & Change Management Specialist II contributes to organizational effectiveness by improving data quality, reducing implementation errors, and strengthening change execution processes.

Requirements

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.
Bachelor's degree or equivalent experience in Business, Manufacturing, Engineering, Quality, Information Management, or related discipline.
Minimum 3 years of relevant experience.

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 accuracy, completeness, and consistency of information prior to 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.
Work with stakeholders to obtain missing information and resolve issues.
Recommend corrective actions to improve information quality and implementation effectiveness.
Support investigation 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 efficiency, accuracy, and effectiveness of change implementation processes.
Assist with development of work instructions, job aids, and process documentation.
Support implementation of process improvements and standardization efforts.