Quality Specialist

• Support deployment of quality strategy at a global organizational level, including quality culture, systems, tools, and competent teams
• Assist the organization in achieving prevention, continuous improvement, robust root cause analysis, quick response, and sustainable problem solutions
• Collaborate with necessary functions to achieve quality targets and world-class performance
• Participate in defining and implementing short-, medium-, and long-term strategy, activities, and planning for the quality management system
• Perform audits and/or ensure audits are performed to assess compliance with the defined system
• Promote the vision of zero defect and establish mechanisms to fulfill ABB, customer, and stakeholder requirements
• Act as process owner for defined quality-related processes, systems, or tools
• Define and document plans, implement and communicate actions, supervise and control progress, and drive continuous process improvement

Senior Quality Specialist advancing quality systems for ABB’s power distribution solutions

Senior Quality Specialist

Senior Quality Specialist advancing quality systems for ABB’s power distribution solutions. Driving audits, zero-defect initiatives, root-cause resolution, and continuous improvement.

• Supports the Technical Director in maintaining a compliant Quality System for Grifols USA (GUSA) in accordance with FDA 21 CFR and Good Distribution Practices (GDP).
• Conduct Supplier Audits to ensure products distributed comply with U.S. regulatory requirements and applicable procedures.
• Perform Internal Audits to ensure GUSA Quality Systems are compliant with Good Distribution Practices (GDP) and applicable procedures.
• Support Distribution Quality System records, including CAPAs, deviations, and complaints, ensuring they are properly reported, documented, and resolved in a timely manner.
• Support returns management and inventory control activities to ensure traceability and GDP compliance.
• Manage customers of distributed medicinal products to ensure compliance with GDP, including qualification and requalification through risk assessments, desk audits, and on-site audits.
• Manage change controls within the Veeva QMS system.
• Manage the qualification and requalification of distributors, 3PLs, product and service providers, and transportation partners in accordance with regulatory requirements and Global Marketing decisions; ensure all (re)qualification records are maintained and archived per established procedures.
• Perform and maintain annual risk assessments related to distribution activities.
• Develop, review, and update procedures to ensure departments involved in product distribution are appropriately integrated into the Quality System.
• Assist the Technical Director in ensuring Quality System remains compliant with applicable regulatory requirements.
• Serve as Training Coordinator by establishing training profiles for new employees and ensuring new or revised procedures are assigned within the training system.
• Develop and deliver training presentations to cross‑functional departments to communicate quality system updates, including new corporate procedures and regulatory requirements that may impact operations.
• Supports Quality KPI monitoring and reporting.

Supports Quality System compliance for healthcare company Grifols in the USA

Supports Quality System compliance for healthcare company Grifols in the USA, overseeing audits and regulatory adherence within a global quality framework.

• Serve as Vaya’s RHTP QAPI point of contact and manage & coordinate the development and implementation of internal QAPI activities and implementation of QAPI initiatives.
• Manage and coordinate the development and implementation of internal Quality Assurance Performance Improvement (QAPI) activities and implementation of Hub and/or governing board QAPI initiatives.
• Develop, implement, and evaluate QAPI processes and procedures to monitor and ensure the quality and timeliness of contracted Hub functions.
• Develop and implement stakeholder feedback tools. Gather reports from responsible individuals and other key staff; facilitate QI activities; and compile regular reporting for bi-directional flow of information among the Hub and governance body.
• Conduct regular review and analysis of quality and performance measures, surveys and assessments, incidents, and other data sources to identify quality and performance deficits.
• Design and implement Performance Improvement Projects (PIPs) and other QAPI processes to identify and address quality and performance issues.
• Provide support for the Hub to identify, aggregate, and report barriers to the governance body.
• Develop and strengthen processes to ensure compliance with and timeliness for required reporting, assessments and surveys, and other data submissions, and other required data submissions and reporting tools.
• Provide support as needed for Hub team members to develop and implement data collection tools and procedures to ensure all program requirements are met to support tracking, monitoring, reporting, and to evaluate and ensure the quality of Hub services and functions.
• Assist and support ongoing and ad hoc QAPI responsibilities of the Quality Management department.

Quality Improvement Specialist managing QAPI activities for Vaya Health

Quality Improvement Specialist

Quality Improvement Specialist managing QAPI activities for Vaya Health, ensuring quality assurance and improvement initiatives. Collaborating with teams to fulfill program requirements and support quality of services.

• Lead and organize training for all Quality Specialists on audit processes, procedures, and tools.
• Conduct complex audits and verifying quality standards for selected inquiries and make decisions whether discrepant information meets BCBSA and FEP audit requirements, state, and federal mandates.
• Provide second-level support on escalated issues and audit findings.
• Collaborate with team members, OCLD, and management to identify training gaps and business needs and implement actions while partnering to address these issues.
• Review, evaluate, and provide feedback on trainees’ audits and learning processes.
• Act as a consultant with external departments to help resolve high-impact business issues by recommending action plans related to quality assurance.
• Assist the Data Reporting Analyst in collecting data and providing analyses for various issues across the department and other functional areas.
• Foster a training and auditing culture that values diversity of thought, leveraging team member strengths to achieve team goals.
• Assist with external audits and lead special projects.
• Perform other duties as assigned.

Quality Specialist III ensuring compliance and conducting complex audits at Premera.

Quality Specialist III

Quality Specialist III role at Premera focusing on compliance, quality assurance, and auditing within healthcare services.

Quality Specialist jobs in North Carolina

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Senior Quality Specialist

Senior Quality Specialist

Quality Improvement Specialist

Quality Specialist III