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

djZNbmVob3duOURqaW54bE1tOUNBSVM0VVE9PQ==
  • 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

Sound Physicians

Emergency Medicine Physician Job at Sound Physicians

Join a dynamic team and become the next Emergency Medicine Physician in Hobbs, NM. In Hobbs, we strive to deliver " better " to our community- better care, better collaboration, and a heartfelt dedication to those we serve. If you're seeking a role that fosters...

Soliant

Remote Special Ed Teacher - Portsmouth, NH Schools Job at Soliant

 ...Role Description We seek a passionate Special Education Teacher to provide virtual services to students in the Portsmouth area....  ...meetings Strong problem-solving skills for adapting instruction to online environments Excellent organizational capabilities for... 

SFBA Tax Resolution INC

Enrolled Agent Job at SFBA Tax Resolution INC

 ...Job Description Job Description Job Summary: We are seeking an experienced Enrolled Agent (EA) with 4-5 years of experience to focus on tax issue resolution. In this role, you will assist clients with debt negotiations and collection actions, working to resolve... 

DLM Pro

Class A CDL Driver - Heavy Haul Job at DLM Pro

 ...Job Title: Class A CDL Driver Heavy Haul Company Overview: Join a team that values skilled drivers and prioritizes their success...  ...Refrigerators available upon request ~ Orientation package: Flights, car rentals, single rooms, and all meals covered (spouses welcome!)... 

Accounting Career Consultants

Senior Accounting Specialist Job at Accounting Career Consultants

 ...This position provides the chance to work in a collaborative environment where accuracy and problem-solving are valued. As a Senior Accounting Specialist, you will play an integral role in ensuring financial data is recorded and reconciled properly while supporting both...