Quality Assurance Engineer - #257157
Job in
Arlington Heights, Cook County, Illinois, 60005, USA
Listed on 2026-08-18
Listing for:
Medix™
Full Time
position Listed on 2026-08-18
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering
Job Description & How to Apply Below
Job Title: Quality Assurance Engineer / Specialist (NCMR Remediation)
Location: On-site (Standard 1st Shift: 8:00 AM – 5:00 PM)
Industry: Medical Device / Pharmaceuticals
About the RoleAre 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.
- 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.
- Availability: Ability to work on-site, standard 1st shift hours (8:00 AM – 5:00 PM).
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