Sr Spec Quality Process

Medline Industries, LP; Northfield (MN); On-site; USD 92,000 - 138,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP in Northfield, MN seeks an experienced Quality professional to design, integrate, and maintain global complaint management and vigilance processes. You will support regulatory reporting, coding standards, IT system requirements, and data governance across medical devices, pharma, and related products.

The role emphasizes continuous improvement, cross-functional collaboration with Quality, Regulatory Affairs, IT, and Operations, and contributing to CAPA and inspection

Qualifications

• Bachelor’s degree in a scientific, engineering, healthcare, or related technical discipline.
• At least 4 years of experience in medical device or pharmaceutical Quality, complaint management, post-market surveillance, regulatory reporting, investigations, Pharmacovigilance or related regulated processes.

Responsibilities

• Administer, maintain, and support governance of global complaint management and regulatory reporting processes and quality systems.
• Collect, analyze, and report quality data to track performance and compliance.
• Develop and implement improvements to processes and procedures in complaints, investigations, device vigilance, and regulatory reporting.
• Collaborate with cross-functional teams to deploy and integrate quality processes and systems.
• Support hosting regulatory audits and inspections, including inspection-readiness.

Skills

FDA knowledge & QSR

Quality systems

MS Office / MS Visio / MS Project / M-

Data analysis

Education

Bachelor’s degree in science/engineering/healthcare

Tools

SAP

ETQ Reliance

Job description

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.

PREFERRED JOB REQUIREMENTS

• Education: None.
• Certification / Licensure: None.
• Work Experience: Experience with Medical Device and Pharma, 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 implementation of standardized Quality processes across multiple business units or geographic regions.
• Experience with SAP.
• Experience with ETQ Reliance.
• Knowledge / Skills / Abilities: Knowledge of post-market surveillance global complaint management, medical device vigilance, regulatory reporting, complaint coding/data standards, process governance, and Quality Management System principles.

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.
• 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, Minitab.
• Position requires travel up to 10% of the time.

Benefits and Compensation

• Salary range: $92,000.00 - $138,000.00 Annual (actual salary will vary based on applicant’s location, education, experience, skills, and abilities).
• Bonus and/or incentive eligible.
• Health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average.
• For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best.

Explore our Belonging page here.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

Through our culture of belonging, our agile and resilient global team is determined to get our customers exactly what they need, at the right time, every time. If you’re a self-starter, eager to grow your career within a high-performing environment, this is the place for you.

Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care. Through its broad product portfolio, resilient supply chain and leading clinical solutions, Medline helps healthcare providers improve their clinical, financial and operational outcomes. Headquartered in Northfield, Illinois, the company employs more than 43,000 people worldwide and operates in more than 100 countries and territories. To learn more about how Medline makes healthcare run better, visit www.medline.com.