Configuration Control & Change Management Specialist II

Cqmedical; Pennsylvania; On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical Coverage

Dental Coverage

Vision Coverage

Life Insurance

Disability Insurance

401(k) Matching

PTO & Holidays

Job summary

Cqmedical seeks a Configuration Control & Change Management Specialist II to lead change activities, maintain data integrity, and coordinate across Engineering, Manufacturing, Quality, and Regulatory Affairs. This role emphasizes accurate records, stakeholder collaboration, and process improvement in a regulated environment.

Responsibilities include data quality assurance, change implementation oversight, and mentorship of junior specialists, with a focus on timely, compliant execution of

Qualifications

• 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.

Responsibilities

• 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 and resolve issues with stakeholders.
• Coordinate activities with Engineering, Manufacturing, Quality, Regulatory Affairs, and other functions.
• Support training of Configuration Control & Change Management Specialist I personnel.

Skills

Change management

Data integrity

Stakeholder coordination

Analytical skills

Communication

Organizational skills

Education

Bachelor's degree or equivalent in related discipline

Tools

ERP

PLM

QMS

LMS

Job description

Configuration Control & Change Management Specialist II

Location: Showing 1 location

Description

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.

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

• Bachelor's 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.

Benefits

Medical, Dental, and Vision coverage starts on Day One!
Freelife 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!

Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities

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