Senior Quality Engineer – Medical Devices & CAPA Leader

Nypro DR; Gurnee (IL); On-site; USD 83,000 - 150,000; Full time

Benefits offered by this job

Competitive base salary

Medical, Dental, Vision Insurance with

HSA options

401K match

Employee Stock Purchase Plan

Paid Time Off

Tuition Reimbursement

Life, AD&D and Disability Insurance

Commuter Benefits

Job summary

Jabil is seeking a Quality Engineer III to lead quality plans and programs for medical device manufacturing. The role emphasizes statistical analysis, CAPA, and continuous improvement within ISO 13485/9001 environments, interfacing with cross-functional teams to ensure regulatory compliance and product quality.

Ideal candidates have 5+ years in medical device or injection molding contexts, strong analytical skills, and hands-on experience with quality systems and Lean practices.

Qualifications

• Degree in Science/Engineering or equivalent.
• 5+ years of medical device or injection molding experience.
• Knowledge of 13485 and/or ISO 9001 Quality Management Systems.

Responsibilities

• Develops, modifies, applies, and maintains quality evaluation and control plans and protocols for processing materials into finished products.
• Analyzes inspection and testing processes; conducts QA tests; performs statistical analysis.
• Audits quality systems for deficiency identification and correction.
• Implements changes to the validation and qualification program.
• Supports and champions change controls related to customer, supplier, and internal changes.
• Leads CAPA actions and ensures documentation compliance with requirements.
• Leads investigation team and documents responses to ensure timely resolution of customer complaints.
• Mentors Quality Engineers and trains employees in quality requirements.
• Supports safety and quality programs and initiatives.

Skills

Quality control statistics

Lean manufacturing

Statistical analysis

CAPA

ISO 13485/9001 knowledge

Quality systems

Team mentoring/leadership

Computer skills (MS Office)

Education

Science/Engineering degree or equivalent

Tools

Excel

Word

PowerPoint

MS Office

Job description

Jabil is seeking a Quality Engineer III to lead quality plans and programs for medical device manufacturing. The role emphasizes statistical analysis, CAPA, and continuous improvement within ISO 13485/9001 environments, interfacing with cross-functional teams to ensure regulatory compliance and product quality.

Ideal candidates have 5+ years in medical device or injection molding contexts, strong analytical skills, and hands-on experience with quality systems and Lean practices.