
JOB SUMMARY
The Sr. Quality Engineer at Jabil Gurnee is a role for a highly experienced and meticulous contributor who enjoys leading initiatives and driving positive change. This role will develop, implement and maintain quality assurance plans, analyze data to drive continuous improvement, and provide technical mentorship to the Quality Assurance team.
Key Responsibilities and End Results: (Essential responsibilities include but are not limited to the following):
Quality System Management: Develop, maintain, and improve quality management system procedures to support governing standards (e.g., ISO 13485, QMSR)
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Root Cause Analysis: Lead root cause analysis sessions with cross-functional working groups and assist with implementing corrective and preventive actions (CAPA) for non-conformances.
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Continuous Improvement: Analyze production/development data to identify trends, defects, and opportunities for improvement.
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Validation & Testing: Support and review the execution of process validation protocols and test method validation. Development of measurement methods (MSA) or functional test methods may be in scope.
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Customer Feedback: Interact with customers on a consistent basis regarding reported non-conformances, oversee internal investigations, and control messaging back to the customer to ensure timely quality-related responses.
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Supplier Quality: While supplier quality is managed by a centralized group, the site is responsible for trending supplier performance issues and managing immediate resolutions with supply chain.
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Leadership/Mentoring: Train and mentor junior/mid-level quality engineers
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Compliance and Audits: Support the Quality Manager with both regulatory and customer audits as needed.
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Key Performance Metrics: Support the Quality Manager with monitoring and driving the reduction of non-conformances, improve process capability, successful audit results, and timely completion of CAPA actions.
Job Specifications: The minimum education and experience required to perform this job competently.
EDUCATION AND MINIMUM EXPERIENCE
Bachelor’s degree in engineering, Quality, or related technical field.
Experience: 7+ years of experience in a quality engineering role, preferably in medical device manufacturing.
Technical Skills: Proficiency in statistical analysis, statistical process control (SPC), root cause
Analysis tools (e.g., fishbone, 5 Whys), and risk management (PFMEA)
Certifications: ASQ Certification (CQE, CQA) preferred
Skills: Strong analytical, leadership, and communication skills
Experience with ISO 13485
Proficiency with Minitab
Standard Microsoft Office Suite, Excel, ERP systems (SAP, Oracle, IQMS)
Organization Linkages: List the titles of individuals and organizations with which this position has the most frequent and significant contact. Briefly describe the nature of those contacts.
Work Cell Managers: Customer Feedback, Change Control
Engineering: Validation, Change Control
Maintenance: Preventative Maintenance, Validation, Process Control
Tooling: Preventative Maintenance, Validation, Process Control
Production Supervisors: Product Non-Conformances and Process Improvement/Data Trending
Business Unit: Customer Related Feedback/Issues and Validations
Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, age, disability, genetic information, veteran status, or any other characteristic protected by law.