Senior Quality Engineer

Sterling Engineering; Libertyville (IL); On-site; USD 69,000 - 83,000; Full time

Benefits offered by this job

Health Insurance

Paid Holidays

PTO

More Benefits

Job summary

Sterling Engineering in Libertyville, IL seeks a Senior Quality Engineer to support a medical device manufacturing operation. You will bring hands-on quality leadership for NPI, risk analysis, PFMEA/FMEA, CAPA, inspection planning, and root cause analysis.

The role collaborates with manufacturing, engineering, calibration, and cross-functional teams, with customer interaction as needed. Strong background in medical device quality systems is essential.

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

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.

Skills

Quality Engineering

NPI

FMEA/PFMEA

CAPA

Root Cause Analysis

Inspection Planning

ISO 13485

Cross-Functional Teams

Customer Interaction

Problem Solving

Education

Bachelor's degree in Engineering/Quality/Manufacturing

Job description

• 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.
• 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.