Quality Assurance Manager

Quality Assurance / Quality Manager – Medical Devices

Location: Chicago area (Headquarters)

Employment Type: Full-Time

Position Summary

The Quality Manager is responsible for leading the Quality Assurance function and overseeing the Quality Management System (QMS) to ensure that all medical devices comply with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and other applicable global regulatory requirements. This role focuses on both process and product quality assurance, driving continuous improvement in product quality, patient safety, and regulatory compliance across the organization. The position provides leadership to cross-functional teams and serves as a primary contact for audits, inspections, and quality-related regulatory interactions

Key Responsibilities

• Develop, implement, and maintain the QMS in compliance with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and other relevant medical device standards.
• Develop, implement, and maintain quality system processes, including procedures for design control, production, process validation, and post-market activities.
• Lead and oversee quality assurance and quality control activities, including product testing, inspections, equipment qualification, and validation processes.
• Support the creation, review, approval, and continuous improvement of SOPs, work instructions, forms, and quality documentation.
• Lead investigations of non-conformances, customer complaints, and quality incidents; manage CAPA, root cause analysis, and effectiveness verification to prevent recurrence.
• Ensure robust change control processes are implemented and documented in compliance with regulatory and internal requirements.
• Participate in and oversee risk management activities (e.g., per ISO 14971), including FMEA, design risk analysis, and process risk assessments.
• Collaborate with R&D and Manufacturing to ensure design and process validation, verification, and transfer activities meet regulatory and QMS requirements.
• Support and manage document control, ensuring accurate, complete, and compliant Device History Records (DHR), Design History Files (DHF), and technical files.
• Lead preparation for and execution of internal audits; coordinate external audits and inspections by FDA, notified bodies, and other regulatory or certification authorities.
• Contribute to supplier quality management, including supplier qualification, audits, performance monitoring, and resolution of supplier-related quality issues.
• Participate in post-market surveillance activities, including complaint handling, MDRs/adverse event reporting, trend analysis, and implementation of corrective actions.
• Assist in regulatory submissions and compliance reviews related to product development, lifecycle changes, and market access.
• Monitor, analyze, and report quality performance metrics and trends to senior management, recommending and driving improvement initiatives.
• Train, mentor, and develop staff on quality policies, procedures, tools, and regulatory requirements, fostering a culture of quality and compliance.
• Stay current with regulatory changes, standards updates, and best practices in medical device quality and incorporate them into the QMS and processes.
• Coordinate with global/offshore teams as needed to ensure alignment of quality processes and standards.

Qualifications

• Bachelor's degree or higher in engineering, bioscience, biomedical engineering, quality management, or related technical discipline.
• 5–10 years of experience in quality management/quality assurance within the medical device industry, including building and managing QMS systems.
• In-depth knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and related global medical device standards and regulations.
• Proven experience in leading or participating in FDA inspections and third-party audits (e.g., notified bodies, certification bodies).
• Direct experience managing CAPA, complaints, post-market surveillance systems, and MDR/adverse event reporting processes.
• Strong understanding of medical device manufacturing processes, design control, validation, and statistical quality control methods.
• Excellent documentation skills and experience maintaining quality records (DHR, DHF, technical files) in compliance with regulatory standards.
• Strong analytical and logical thinking skills with the ability to interpret data, identify issues, and propose effective, data-driven solutions.
• Highly detail-oriented with strong organizational skills and the ability to manage multiple priorities in a fast-paced environment.
• Exceptional communication and leadership skills, with experience collaborating across functions and training teams.
• High proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook) and familiarity with quality management software tools.

Preferred Attributes

• Experience with Class II or III medical devices and global markets (e.g., EU MDR, Health Canada, other international regulators).
• Knowledge of lean manufacturing, Six Sigma, or other continuous improvement methodologies; related certifications are a plus.
• Certification in quality (e.g., ASQ CQM, CQE, CQA) or regulatory affairs is desirable.
• Willingness and ability to participate in occasional international travel (e.g., Pakistan, India, Saudi Arabia) to engage with offshore or partner teams, if required