Senior Quality Engineer

Senior Quality Engineer

Job Title: Quality Engineer

Company: Intellectt Inc.

Location: Libertyville, IL (Onsite)

Employment Type: Contract (12 Months)

Job Responsibilities:

• Set up, operate, and troubleshoot molding processing equipment in a high-volume medical device manufacturing environment.
• Perform quality testing and inspections to ensure products meet specifications and established quality standards.
• Develop and execute Process Failure Mode and Effects Analysis (PFMEA) for molding processes.
• Apply Design of Experiments (DOE) and process characterization techniques to evaluate and optimize manufacturing processes.
• Drive continuous improvement initiatives, root cause analysis, and problem-solving activities to improve product quality and manufacturing efficiency.
• Conduct process test runs, analyze results, and identify production yield issues and opportunities for improvement.
• Prepare quality records, technical reports, charts, and graphs to document process performance and present test results.
• Provide technical assistance to process development and engineering teams for process optimization and manufacturing improvements.
• Ensure compliance with ISO 13485 and applicable medical device quality standards.
• Communicate with customers and internal stakeholders regarding quality issues, process performance, and corrective actions.

Required Qualifications:

• Bachelor of Engineering (B.E.) degree or equivalent engineering qualification.
• 5-7 years of experience in quality engineering within a manufacturing environment.
• Hands-on experience with molding processes, preferably injection molding, including equipment setup and operations.
• Strong knowledge of PFMEA, Design of Experiments (DOE), process characterization, and quality testing.
• Experience in high-volume medical device manufacturing.
• Knowledge of ISO 13485 and applicable medical device quality standards.
• Experience with continuous improvement, root cause analysis, problem-solving, and production yield improvement.
• Ability to analyze test results and prepare quality documentation, reports, charts, and graphs.

Pay Scale:

• Anticipated hourly pay range: $38-40/hr on W2.

Benefits:

Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:

Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

• Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.