Quality Engineer

Job Description

Job Description

Senior Quality Engineer

Location: Libertyville, IL
Employment Type: Contract

Benefits: Insurance (Health, Medical, Dental), Paid Holidays, PTO, and More!
Schedule: Full-Time

Compensation: $50-$60/hr (W2)

Overview

We are seeking an experienced Senior Quality Engineer to support a medical device manufacturing operation in Libertyville, IL. This is an urgent need for a hands-on Quality Engineer who can step in and contribute with minimal training or ramp-up time.

The ideal candidate will have a strong background in medical device manufacturing and proven experience supporting New Product Introduction (NPI), risk analysis, PFMEA/FMEA, CAPA, inspection planning, and root cause analysis. This role will work closely with manufacturing, engineering, calibration, and other cross-functional teams, and may also involve direct interaction with customers.

This is a great opportunity for a quality professional who enjoys solving problems, supporting new products, and being a resource to the organization.

Key Responsibilities

• Support New Product Introduction (NPI) projects from a quality engineering perspective.

• Lead and participate in risk analysis, FMEA/PFMEA, and other quality planning activities.

• Develop and implement inspection plans and support inspection planning activities.

• Lead and support CAPA investigations through root cause analysis, corrective action, and effectiveness activities.

• Perform root cause analysis and assist with the resolution of manufacturing and product quality issues.

• Partner with manufacturing and engineering teams to identify and implement process and product improvements.

• Support calibration teams and related quality activities.

• Complete and maintain quality-related data sheets, documentation, and records.

• Ensure processes and documentation align with applicable medical device quality requirements, including ISO 13485.

• Participate in cross-functional project teams and communicate quality requirements, risks, and findings clearly.

• Interact with customers as needed regarding quality-related issues and project activities.

• Support continuous improvement and help ensure products and processes meet quality and customer requirements.

Required Qualifications

• Bachelor’s degree in Engineering, Quality, Manufacturing, or a related technical field.

• 6+ years of Quality Engineering experience in a medical device manufacturing environment.

• Strong experience supporting New Product Introduction (NPI).

• Hands-on experience with FMEA/PFMEA and risk analysis.

• Strong CAPA experience, including root cause analysis and corrective action.

• Experience developing, implementing, or leading inspection plans.

• Strong understanding of medical device quality systems and ISO 13485.

• Experience working in a manufacturing environment rather than solely in validation or documentation-focused quality roles.

• Strong analytical and problem-solving skills.

• Ability to work independently and make an immediate contribution with limited training or supervision.

• Clear, concise written and verbal communication skills.

• Ability to work effectively with cross-functional teams and, when needed, customers.

Preferred Qualifications

• Strong injection molding experience, particularly in a medical device manufacturing environment.

• Experience with manufacturing processes and process improvement.

• Experience supporting calibration activities.

• Experience working directly with customers on quality-related matters.

Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, or national origin .