Senior Quality Engineer - Manufacturing Excellence & CAPA Lead

Summit Staffing, Inc

Addison (IL)

On-site

USD 70,000 - 100,000

Full time

14 days+

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Job summary

Summit Staffing, Inc. is recruiting an experienced Quality Engineer for an advanced manufacturing operation. This onsite, full-time role emphasizes quality systems, process improvement, and manufacturing excellence.

You will develop and implement process controls, lead root cause analysis, and drive CAPA activities while collaborating with engineering and production teams to prevent issues and ensure product quality.

Qualifications

Bachelor's degree in Engineering.
Certified Quality Engineer (CQE) preferred.
Strong knowledge of ISO 9001 quality systems and audit requirements.
ISO 13485 / medical manufacturing experience preferred.
5+ years of relevant manufacturing experience.
Strong analytical, problem-solving, and communication skills.

Responsibilities

Develop, document, and implement process controls, SPC, testing, and inspection methods.
Lead root cause analysis and corrective action initiatives.
Drive process improvements to improve quality, efficiency, and consistency.
Lead and support CAPA activities and corrective action.
Conduct internal quality system audits.
Support APQP, product validation, and process verification.
Develop and maintain quality metrics and reporting.
Partner with engineering and production teams to prevent quality issues.
Utilize DOE, DFM, FMEA, GD&T, process capability, and Six Sigma.
Participate in MRB activities and failure analysis.
Develop and support quality training, including blueprint reading and new employee quality training.
Manage larger quality projects and coordinate timelines, resources, and communication.