Jobs · Engineering · Pennsylvania

Configuration Control & Change Management Specialist II

CQ Medical · Avondale, PA · 1 wk ago
On-siteEngineeringFull-time

About the role

The Configuration & Change Management Specialist II plays a crucial role in ensuring that all changes to product structures, bills of material, routings, and controlled information are accurately and completely implemented. This position focuses on maintaining data integrity, coordinating stakeholder activities, and driving process improvements.

Responsibilities

  • Maintain complex product structures, bills of material, routings, and controlled information.
  • Verify 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.
  • 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.
  • Cook 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.
  • Aid in the development of work instructions, job aids, and process documentation.
  • Support implementation of process improvements and standardization efforts.

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.

Preferred Experience

  • 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.

Qualifications

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

Skills

  • 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.

Benefits

  • 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.

Pay

Competitive salary commensurate with experience.

Schedule

Full-time position.

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