Quality Assurance Engineer / Specialist (NCMR Remediation) - Arlington Heights, IL - Onsite

Job Description

About the Role

Are you a hands-on Quality Assurance professional who excels in root cause analysis and thrives in driving compliance? We are seeking a self-motivated QA Specialist / Engineer to jump right in and manage quality event resolutions for our on-site team.

In this role, you will take ownership of evaluating, investigating, and closing an active backlog of 100+ Nonconforming Material Report (NCMR) records and deviations, while collaborating closely with Production and Operations teams to maintain seamless output under FDA and ISO 13485 standards.

Key Responsibilities

NCMR Remediation: Evaluate, process, and drive rapid resolution for an immediate backlog of 100+ open NCMR records and deviations.
Investigations & RCA: Perform thorough complaint investigations and review Device History Records (DHRs) to identify root causes and assign effective corrective actions.
CAPA Support: Participate in Corrective and Preventive Action (CAPA) activities originating from nonconformances and quality event trends.
Cross-Functional Collaboration: Partner directly with on-site Production, Operations, and Quality teams to resolve quality events without interrupting manufacturing schedules.
Compliance & Documentation: Ensure all quality records, investigations, and remediation files comply with FDA, ISO 13485 / cGMP standards and internal procedures.
Required Qualifications

Experience: 5 to 7 years of hands-on Quality Assurance experience within the Medical Device or Pharmaceutical industry.
Core Competencies: Demonstrated expertise handling NCMRs, deviations, complaint investigations, DHR reviews, and CAPA processes.
Regulatory Knowledge: Solid working knowledge of FDA regulations and ISO 13485 / cGMP standards.
Work Style: Proven track record as a self-directed individual contributor capable of ramping up quickly and independently managing high-volume record backlogs.