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 .