Quality System Manager

GForce Life Sciences; Chicago (IL); On-site; USD 130,000 - 150,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401k

Job summary

GForce Life Sciences seeks an experienced Quality Manager to oversee the QMS and drive continuous improvement for medical devices. You will own the QMS, manage CAPAs, vendor quality, and participate in audits with a hands-on, cross-functional approach.

The role requires expertise in ISO 13485 and FDA 21 CFR 820, plus proven ability to lead regulatory inspections and maintain lifecycle quality documentation. Onsite Chicago area employees preferred.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, or related technical discipline.
• 7+ years in Quality Assurance, Quality Systems, or Quality Engineering, including 5+ years in medical device/combination product.
• Strong working knowledge of ISO 13485 and FDA 21 CFR 820 (QMSR).
• Experience maintaining, improving, or managing a regulated Quality Management System.
• Hands-on CAPA, nonconformance management, change control, document control, internal audits, and supplier quality processes.
• Experience owning or administering an electronic Quality Management System (eQMS) with validated software.

Responsibilities

• Own and manage the Quality Management System (QMS) including eQMS administration and document control.
• Lead CAPA investigations, root cause analysis, corrective actions, and effectiveness verification.
• Oversee supplier qualification, evaluation, monitoring, and supplier quality management activities.
• Coordinate internal and external audits, including ISO certification and regulatory inspections; ensure inspection readiness.
• Collaborate with cross-functional teams to embed quality requirements in development and testing activities.

Education

Bachelor's degree in Engineering, Life Sciences, Quality, or a related technical discipline

Job description

Quality Manager, Medical Device / Quality Systems

Summary

Our client, a medical device and combination product development and testing organization, is seeking an experienced Quality Manager to oversee the day-to-day operation, maintenance, and continuous improvement of its Quality Management System (QMS).

This individual will serve as the primary owner of the QMS, ensuring compliance with applicable regulatory requirements, industry standards, and internal procedures. The role requires a hands‑on quality professional who can independently manage quality system processes, drive improvements, support regulatory and client audits, and partner with cross‑functional teams.

Duties / Expectations of Role

Quality Management System (QMS) Ownership

• Own and manage the organization's Quality Management System, ensuring ongoing compliance with ISO 13485, FDA 21 CFR 820 (QMSR), and applicable regulatory requirements.
• Oversee the development, implementation, maintenance, and continuous improvement of quality policies, procedures, SOPs, work instructions, and related documentation.
• Serve as the primary business owner and administrator of the electronic Quality Management System (eQMS), including system configuration, user access, workflows, periodic reviews, and ongoing improvements.
• Oversee computer software assurance and validation activities for regulated quality software, including change assessments, system updates, and revalidation as required.
• Identify quality system gaps, implement corrective improvements, and ensure processes remain effective and inspection‑ready.

CAPA, Nonconformance & Quality Oversight

• Manage quality system processes, including corrective and preventive actions (CAPA), nonconformances, deviations, change control, document control, and quality records.
• Lead CAPA investigations, root cause analysis, corrective action implementation, and effectiveness verification.
• Facilitate CAPA Review Board activities and upscale overdue, high‑risk, or recurring quality issues.
• Monitor quality metrics, identify trends, and drive continuous improvement initiatives to strengthen quality system performance.

Supplier Quality Management

• Oversee supplier qualification, evaluation, monitoring, and ongoing supplier quality management activities.
• Maintain approved supplier lists, supplier risk classifications, and periodic supplier performance evaluations.
• Manage supplier‑related quality issues, including supplier corrective action requests (SCARs), investigations, and follow‑up activities.
• Collaborate with internal stakeholders to ensure suppliers meet applicable quality and regulatory requirements.

Audits, Regulatory Compliance & Inspection Readiness

• Plan, coordinate, and execute internal quality audits to assess compliance with established procedures and applicable regulatory standards.
• Support external audits, including ISO certification and accreditation audits, regulatory inspections, and client quality audits.
• Coordinate audit preparation, documentation requests, inspection support, audit responses, and corrective action follow‑up.
• Maintain ongoing audit and inspection readiness across the organization.
• Support compliance with applicable standards and regulations, including ISO 13485, ISO/IEC 17025, ISO 14971, and relevant FDA requirements.

Training & Management Review

• Oversee the organization's quality training program, ensuring personnel receive appropriate training on quality procedures, regulatory requirements, and eQMS workflows.
• Maintain training documentation and monitor training completion and effectiveness.
• Coordinate management review activities, including preparation of quality metrics, audit findings, CAPA trends, supplier performance, and other quality system inputs.
• Track management review action items through completion and communicate quality system performance to leadership.

Cross-Functional & Client Quality Support

• Partner with Engineering, Laboratory Operations, Regulatory Affairs, and other functional teams to ensure quality requirements are integrated into daily operations.
• Provide quality system guidance and support for medical device and combination product development and testing activities.
• Support client-facing quality initiatives, including QMS development, quality system remediation, procedure development, and Quality Agreements.
• Serve as a quality subject matter expert, providing practical guidance on regulatory compliance, process improvements, and quality system requirements.
• Collaborate with external consultants and technical specialists when needed while maintaining ownership and accountability for quality system activities.

Mandatory Requirements

• Bachelor's degree in Engineering, Life Sciences, Quality, or a related technical discipline.
• Minimum of 7 years of experience in Quality Assurance, Quality Systems, or Quality Engineering, including at least 5 years within the medical device or combination product industry.
• Strong working knowledge of ISO 13485 and FDA 21 CFR 820 (QMSR).
• Experience independently managing, maintaining, or improving a regulated Quality Management System.
• Hands‑on experience with CAPA, nonconformance management, change control, document control, internal audits, and supplier quality processes.
• Experience owning or administering an electronic Quality Management System (eQMS), including regulated software validation or computer software assurance activities.
• Experience supporting regulatory inspections, ISO certification audits, and client quality audits.
• Familiarity with ISO 14971, ISO/IEC 17025, and applicable Good Documentation, Laboratory, and Manufacturing Practices (GDP, GLP, GMP).
• Strong technical writing skills, including experience developing and revising SOPs, quality procedures, and controlled documentation.
• Excellent organizational, communication, problem‑solving, and cross‑functional collaboration skills.
• Ability to work independently, manage competing priorities, and take a hands‑on approach to quality system management.

Nice to Have

• Experience within a medical device contract development organization, contract research organization (CRO), or contract testing laboratory.
• Experience with drug-device combination products.
• Experience serving as a Quality Management Representative (QMR).
• Familiarity with ZenQMS or similar electronic quality management platforms.
• Knowledge of EU MDR, MDSAP, and 21 CFR Part 4.
• ASQ Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or ISO 13485 Lead Auditor certification.
• Experience supervising, mentoring, or providing technical guidance to quality personnel.
• Experience supporting QMS implementation, remediation, or continuous improvement initiatives.

Term & Start

• Full‑time position
• Compensation130,00-150,000
• Onsite preferred; some work‑from‑home flexibility may be available based on business needs. This is not a fully remote position.
• Benefits included (Medical, Dental, Vision, 401k)
• Interview process: Initial recruiter screening using agreed‑upon questions; 45–60‑minute interview with the hiring manager; onsite interview with the extended team.