Sr Spec Quality Process

Medline • Northfield, MN

1d • $92,000 - $138,000

About The Position

Under minimal supervision, the Senior Quality Process Specialist is responsible for designing, integrating, implementing, and maintaining Quality processes, with a focus on global complaint management, investigations, device vigilance, and 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.

As part of the Global Process, Systems & Center of Excellence team, the position supports Quality Systems activities, analyzes quality and regulatory information, and provides process, systems, and technical support. It supports 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 also supports quality solution development and testing, acquisition integration, global process harmonization, IT system changes and integrations, regulatory updates, inspection readiness, and continuous improvement to promote consistent, compliant global practices.

The position requires a bachelor's degree in a scientific, engineering, healthcare, or related technical discipline, or equivalent job-related knowledge, and at least four years of relevant experience in regulated Quality or related processes. Travel is required up to 10% of the time. The anticipated annual salary range is $92,000 to $138,000; the role is eligible for bonus and/or incentives. Benefits are available according to the stated hours-worked eligibility terms.

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 those 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.
• 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/AE system implementation, configuration, validation/testing, integration, and change management.
• Experience supporting acquisition integration, global process harmonization, or standardized Quality process implementation across multiple business units or geographic regions.
• Experience with SAP.
• Experience with ETQ Reliance.
• Knowledge of post-market surveillance, global 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 involving complaint handling, investigations, device vigilance, regulatory reporting, coding, and related 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 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 applicable 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 complaint/AE IT systems, including user requirements, fields, workflows, codes, lists of values, integrations, and business rules.
• Collaborate with Quality, Regulatory Affairs, Medical/Clinical, Product Divisions, Operations, IT, and other 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 activities and CAPA.
• Provide project guidance, training, and coaching.
• Support implementation and integration of global processes, change management, and ongoing governance, including regulatory changes, acquisitions, complaint/AE system implementations, 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 employees working an average of 30 or more hours per week.
• Life and disability coverage, for employees working an average of 30 or more hours per week.
• 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 an average of 30 hours per week.
• Bonus and/or incentive eligibility.

What This Job Offers

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