Quality Engineer - Medical Devices Job at Intellectt Inc, Buffalo Grove, IL

amVKZGVHUytXZlVJenlrZHA0dTZYS0JzMUE9PQ==
  • Intellectt Inc
  • Buffalo Grove, IL

Job Description

Role: Quality Engineer – Medical Devices

Duration: 6-12+ Months

Location: Buffalo Grove, IL

What You’ll Do

  • Lead and manage Quality Assurance (QA) systems, including CAPA, audits, and compliance.
  • Ensure all products, processes, and records meet FDA, ISO 13485, and internal standards.
  • Collaborate cross-functionally to resolve quality issues and improve systems.
  • Analyze QA data, track trends, and report key metrics regularly.
  • Develop and deliver training on quality systems and best practices.
  • Serve as a lead representative during internal/external audits.
  • Investigate non-conformances and drive corrective actions.
  • Mentor and guide other QA team members.
  • Support global initiatives and maintain effective communication across teams.

What We’re Looking For

  • Bachelor’s degree in Engineering or a related technical field (advanced degree a plus).
  • 1-5+ years of QA or engineering experience in a regulated industry (medical device preferred).
  • Strong knowledge of FDA regulations, GMP, and ISO 13485.
  • Proven leadership in QA systems and cross-functional project teams.
  • Skilled in data analysis, reporting, and quality metrics.
  • Excellent communication and problem-solving skills.
  • Experience with CAPA management, audits, and risk assessments.
  • Certifications like ASQ CQE/CQA/CQT and Six Sigma preferred.

Job Tags

Similar Jobs

Challenger Motor Freight Inc

Business Development Manager Job at Challenger Motor Freight Inc

 ...Position Scope: We are looking for talented and competitive Business Development Managers (BDMs) that will thrive in a quick sales cycle environment. Under the guidance of the VP of Sales, these BDMs will play a vital role in supporting profitable sales growth. This... 

ManpowerGroup

Global Human Resources Intern Job at ManpowerGroup

 ...opportunity to help the team automate processes. Compensation Support: Assist in gathering and organizing compensation data for internal analysis. Support the preparation of compensation reports and spreadsheets. Help maintain salary and job classification... 

Medix™

Entry Level Clinic Assistant - 241993 Job at Medix™

 ...environment and work one-on-one with patients and providers in a fast-paced clinical setting. On-the-job training provided ( no experience needed )! Responsibilities: Call patients into the room for appointments. Record patient information using electronic... 

TPI Global Solutions

Information Technology Business Analyst Job at TPI Global Solutions

Position Title: OTM Business Analyst Location: Atlanta, GA Hybrid Expected Duration of Project: 12+ month contract with good chances of extension Job Requirements: ~ Triage day to day system issues and provide resolution for complex systems issues. ~ Resolve...

NavaFlex Inc.

E-Textile Engineer - Full-Time (August 2025 Start) Job at NavaFlex Inc.

 ...more connected worldone thread at a time. Position Overview Were seeking a hands-on, creative, and technically skilled e-Textile Engineer to lead the integration of NavaFlexs cutting-edge energy solutions into smart fabrics. This role bridges advanced...