Senior Quality Compliance Manager

Medline Industries, LP•Chicago, IL

3d•Onsite

About The Position

Provides senior-level Quality leadership focused on the governance, execution, and continuous improvement of the Quality Management System (QMS) and related post-market processes. Owns divisional QMS activities supporting post-market surveillance, complaint handling and investigations, CAPA and SCAR management, supplier quality monitoring, risk management, and lifecycle maintenance of Design History Files (DHF) and CE Technical Documentation. Leads QMS execution across data monitoring, trending, and management review inputs to ensure effective oversight of product performance, system health, and regulatory compliance. Drives corrective actions and systemic improvements through structured analysis of post-market and supplier quality data. Establishes and maintains inspection-ready QMS processes, procedures, and records. Sets operational priorities, oversees resource allocation for QMS activities, and partners cross-functionally to ensure sustained compliance and effective system performance across the full product lifecycle.

Requirements

Typically requires a Bachelor’s degree in Engineering, Science, or Technical Field.
At least 5 years of experience related to the design/operation of medical device or drug combination product platforms, design controls, risk management, including working in compliance with QSR/GMP/ISO requirements or other regulated industries (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR).
At least 2 years of management experience.
Depth of technical knowledge of relevant standards and regulations (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR etc.)
Proficiency in analyzing and reporting data and performing statistical analysis in order to identify issues, trends, or exceptions to drive improvement of results and find solutions.
Demonstrated ability to control and coordinate concurrent projects, competing priorities and critical deadlines.
Advanced skill level in Microsoft Excel (for example: pivot tables and reporting, conditional formatting, tables, formulas, charting, etc.).
Position requires travel up to 30% of the time for business purposes (within state, out of state and/or internationally).

Nice To Haves

At least 4 years of managerial experience preferred.
At least 6 years of related experience in Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products industries preferred.

Responsibilities

Monitor and maintain compliance with applicable QSR/GMP/ISO requirements or other regulated industries (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR) pertaining to the applicable life cycle and regions of distribution for the product.
Governance and execution of Quality Management System.
Oversee the execution to the resolution of all quality issues.
Provides Leadership support during internal/external regulatory audits.
Act as liaison with the Leadership of Divisions, Suppliers, Manufacturing, and/or Operations to ensure quality products, on time delivery, and customer satisfaction.
Devise and implement effective communication strategies with Divisions, Suppliers, Manufacturing, and/or Operations Executives and other internal and external Stakeholders.
Leads the process and team during investigations and identifying resolutions for issues relating to product or production quality by interfacing with Divisions, Suppliers, Manufacturing, and/or Operations.
Devise and implement continuous improvement initiatives, develop and share best practices, and participate in policy setting activities.
Manages team of quality professionals and/or Managers; Oversee major projects/programs/outcomes; Budget responsibility; Interpret and execute policies for departments/projects; Recommend and implement new policies or modifications to existing policies; Provide general guidelines and parameters for staff functioning; Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies.