Manufacturing Quality Engineer

Job Title : Manufacturing Quality Engineer

Location : Illinois (Onsite)

Experience : 5+ Years

Duration : 12+ Months Contract

Job Summary :

The Manufacturing Quality Engineer will be responsible for ensuring that products meet the highest standards of quality, safety, and compliance within a medical device manufacturing environment. This role involves leading quality initiatives, driving continuous improvement, and supporting production processes-particularly in CNC machining and precision manufacturing. The ideal candidate will have hands-on experience with quality systems, leadership capability, and strong problem-solving skills.

Key Responsibilities :

Lead quality assurance and quality control activities for medical device manufacturing.

Develop, implement, and maintain quality processes and systems in compliance with FDA, ISO 13485, and other regulatory requirements.

Oversee and support inspection and testing activities related to CNC machined components and assemblies.

Drive root cause analysis and corrective / preventive action (CAPA) processes to resolve product and process issues.

Collaborate with cross-functional teams including design, manufacturing, and regulatory to ensure product quality and process consistency.

Provide quality engineering support for new product introductions and design transfer to manufacturing.

Lead internal and external audits, supplier quality assessments, and process validations.

Monitor key quality metrics, prepare reports, and recommend improvements for production and quality performance.

Mentor and guide junior team members and inspection staff to ensure compliance and consistency across operations.

Support continuous improvement initiatives using tools such as Lean, Six Sigma, and risk management techniques.

Required Skills and Experience :

Bachelor's degree in Engineering (Mechanical, Manufacturing, Industrial, or related field).

Minimum 5 years of experience in quality engineering within the medical device industry .

Proven leadership or team lead experience in a regulated manufacturing environment.

Strong understanding of CNC machining , precision manufacturing, and inspection processes.

In-depth knowledge of quality standards and regulations (FDA 21 CFR Part 820, ISO 13485, ISO 9001).

Experience with CAPA , risk management , process validation , and supplier quality .

Proficiency in quality tools such as FMEA, control plans, PPAP, SPC, and MSA.

Hands-on experience with metrology tools, GD&T, and blueprint reading.

Excellent analytical, communication, and organizational skills.

Preferred Qualifications :

ASQ Certified Quality Engineer (CQE) or equivalent certification.

Experience with CAD models, ERP / MRP systems, and statistical analysis software (e.g., Minitab).

Exposure to Lean Manufacturing or Six Sigma projects.