Sr Spec Quality Process

Job Summary

Under minimal supervision, responsible for Quality process design, integration, implementation, and maintenance, with a focus on global complaint management, investigations, device vigilance, regulatory reporting processes, systems, and standards. Manage the integrity and standardization of complaint and investigation processes, regulatory reporting frameworks, coding standards, and associated data and systems for Medline products, including but not limited to medical devices, pharmaceuticals, biologics, cosmetics, medical foods, and dietary supplements.

Support Quality Systems related activities; analyze problems related to quality/regulatory information; and provide process, systems, and technical support in solving these problems. Support governance and maintenance of global complaint and vigilance procedures, work instructions, reportability frameworks, coding standards, IT system requirements, workflows, fields, codes, lists of values, and business rules.

Support design, development, implementation, and testing of quality solutions and business acquisition integration as required to meet customer/regulatory requirements, and work with internal and external inputs to develop these solutions. Support global process harmonization, IT system changes, integrations, regulatory-driven updates, inspection readiness, and continuous improvement of complaint management and vigilance processes.

The position functions as part of the Global Process, Systems & Center of Excellence team, supporting consistent and compliant complaint and vigilance processes, systems, data standards, and practices across the organization.

Job Description

MAJOR RESPONSIBILITIES:

• Administer, maintain, and support governance of global complaint management and regulatory reporting processes and associated quality systems, including procedures, work instructions, regulatory reporting frameworks, vigilance assessment, coding standards, and process requirements.
• Collect, analyze, and report quality data to track performance and compliance. Develop and implement improvements to processes and procedures, including complaint handling, investigations, device vigilance, regulatory reporting, coding, and associated process and system controls.
• Identify and advise on opportunities to improve processes and systems that support the success of global process harmonization, compliance, and effective complaint and vigilance operations.
• Track performance and compliance of key quality metrics/indicators, including operational and management review metrics supporting complaint management, investigations, vigilance, regulatory reporting, coding, process effectiveness, and system/data quality.
• Reviews and determine the application of various system compliance regulations. Ensure compliance to global regulatory requirements with internal procedures. Identify risk and compliance opportunities.
• Support development, implementation, testing, and maintenance of complaint/AE IT system, including user requirements, system fields, workflows, codes, lists of values, integrations, and business rules.
• Collaborate with cross-functional teams across Quality, Regulatory Affairs, Medical/Clinical, Product Divisions, Operations, IT, and other applicable business functions, to deploy and integrate quality processes and systems . Consult and provide guidance to business partners.
• Support hosting regulatory audits and inspections, including inspection-readiness support and CAPA.
• Provide project guidance, training, and coaching. Support implementation and integration of global processes, change management, and ongoing governance, including new or revised regulatory requirements, acquisitions, IT complaint/AE system implementation, system enhancements, integrations, and event-driven process changes.
• Serve as a Center of Excellence resource for post-market processes, systems, standards, best practices, process standardization, global harmonization, training support, and continuous improvement.

MINIMUM JOB REQUIREMENTS:

Education

A bachelor’s degree in a scientific, engineering, healthcare, or related technical discipline, or equivalent job-related knowledge.

Certification / Licensure

None.

Work Experience

At least 4 years of experience with medical device or pharmaceutical Quality, complaint management, post-market surveillance/device vigilance, regulatory reporting, investigations, Pharmacovigilance, Quality Systems, or related regulated processes.

Knowledge / Skills / Abilities

• Knowledge of Food and Drug Administration (FDA), Quality System Regulations (QSR) and International Organization for Standardization (ISO) requirements, including requirements applicable to post-market surveillance.
• Working knowledge of quality system process development, controlled documentation, process governance, and implementation within a regulated environment.

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