Analysis Skills, Bill of Materials (BOM), Cancer, Change Control, Change Management, Communication Skills, Configuration Management, Corrective Action, Cross-Functional, Data Processing, Data Quality, Document Management, Documentation, ERP (Enterprise Resource Planning), Establish Priorities, Follow Through, Manufacturing, Medical Equipment, Organizational Development/Management, Organizational Skills, Problem Solving Skills, Process Improvement, Product Lifecycle Management, Product Reviews, Quality Management, Radiation Therapy, Regulations, Technical Support
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.
Essential Responsibilities
Configuration & Data Integrity
- 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.
Change Implementation
- 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.
Information Quality & Problem Resolution
- 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.
Cross-Functional Support
- 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.
Process Improvement
- 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.
Knowledge, Skills & Abilities
Required
- 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.
Preferred
- 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.
Education & Experience
Required
- Bachelors degree or equivalent experience in Business, Manufacturing, Engineering, Quality, Information Management, or related discipline.
- Minimum 3 years of relevant experience.
Preferred
- Experience with ERP, PLM, QMS, and document management systems.
- Medical device or regulated industry experience.
Medical, Dental, and Vision coverage starts on Day One!
Free life insurance, short and long-term disability insurance, Telehealth Appointments, and Employee Assistance Program.
Immediate vesting of 401(k) matching. Generous PTO and 11 Paid Holidays a year. And, most importantly...truly meaningful work!
Would you like to make a difference in the lives of cancer patients and their families? We design and manufacture radiation oncology medical devices to ensure more accurate, comfortable treatment for cancer patients. CQ Medical is the global market leader in patient positioning. As an innovative medical device company, we focus on discovering, developing, and distributing technology-driven solutions to improve outcomes for radiotherapy patient positioning.
We are continuing to grow and expand our products. Join us and earn a Paycheck with a Purpose. www.cqmedical.com