Sr Spec Quality Process

Medline Industries, LP • Mundelein, IL

3d • $92,000 - $138,000

About The Position

Under minimal supervision, the Senior Specialist, Quality Process is responsible for designing, integrating, implementing, and maintaining quality processes, with a focus on global complaint management, investigations, device vigilance, regulatory reporting processes, systems, and standards. The role manages the integrity and standardization of complaint and investigation processes, regulatory reporting frameworks, coding standards, and associated data and systems for Medline products, including medical devices, pharmaceuticals, biologics, cosmetics, medical foods, and dietary supplements.

The position supports Quality Systems activities by analyzing quality and regulatory information issues and providing process, systems, and technical support. It contributes to 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.

The role supports the design, development, implementation, and testing of quality solutions and business acquisition integration to meet customer and regulatory requirements. It also supports global process harmonization, IT system changes and integrations, regulatory-driven updates, inspection readiness, and continuous improvement. As part of the Global Process, Systems & Center of Excellence team, the position promotes consistent and compliant complaint and vigilance processes, systems, data standards, and practices across the organization.

Requirements

• Bachelor’s degree in a scientific, engineering, healthcare, or related technical discipline, or equivalent job-related knowledge.
• 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 of FDA Quality System Regulations (QSR) and ISO requirements, including requirements applicable to post-market surveillance.
• Working knowledge of quality system process development, controlled documentation, process governance, and implementation in a regulated environment.
• Ability to develop and maintain procedures, work instructions, process flows, business rules, requirements, coding standards, and other controlled process documentation.
• Proficiency in Microsoft Suite, MS Visio, MS Project, and Minitab.
• Ability to travel up to 10% of the time.

Nice To Haves

• Experience with medical devices and pharmaceuticals, multiple product types, and regulatory jurisdictions.
• Experience with quality systems development and implementation.
• Experience with complaint/adverse-event system implementation, configuration, validation/testing, integration, and change management.
• Experience supporting acquisition integration, global process harmonization, or implementation of standardized Quality processes across multiple business units or geographic regions.
• Experience with SAP.
• Experience with ETQ Reliance.
• Knowledge of global post-market surveillance complaint management, medical device vigilance, regulatory reporting, complaint coding/data standards, process governance, and Quality Management System principles.

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 supporting global process harmonization, compliance, and effective complaint and vigilance operations.
• Track performance and compliance of key quality metrics and indicators, including operational and management review metrics for complaint management, investigations, vigilance, regulatory reporting, coding, process effectiveness, and system and data quality.
• Review and determine the application of system compliance regulations; ensure compliance with global regulatory requirements and internal procedures; and identify risk and compliance opportunities.
• Support development, implementation, testing, and maintenance of the complaint/adverse-event 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 with and provide guidance to business partners.
• Support 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/adverse-event 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.

Benefits

• Competitive total rewards package.
• Continuing education and training.
• Health insurance for eligible employees.
• Life insurance for eligible employees.
• Disability insurance for eligible employees.
• 401(k) contributions.
• Paid time off.
• Access to the Employee Assistance Program, Employee Resource Groups, and the Employee Service Corp for employees working less than 30 hours per week.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior