Quality Engineer

Job Title: Quality Engineer

Job Location: Madison, WI

Job Duration: Contract

Interview: Virtual

Job Summary:

The Quality Engineer will be responsible for supporting and enhancing Quality Systems within a manufacturing environment. This role involves handling product complaint investigations, root cause analysis (RCA), manufacturing quality process development, deviation investigation, CAPA management, change management, internal/external auditing, and supplier quality management. The position requires cross-functional collaboration to drive a strong quality culture.

Key Responsibilities:

• Perform data analysis and trend customer complaints.
• Manage deviations and non-conformance reports from initiation to resolution.
• Lead root cause investigations with cross-functional teams.
• Develop and maintain manufacturing quality control processes.
• Support supplier quality management, including audits and agreements.
• Maintain and improve Failure Mode and Effects Analysis (FMEA) for production areas.
• Oversee CAPA creation and effectiveness.
• Ensure compliance with cGMP and regulatory requirements.
• Review and approve quality procedures, protocols, and reports.
• Conduct internal and external audits.

Qualifications & Skills:

• Bachelor's degree in Engineering, Science, or a related field.
• 3 years of experience in a cGMP Quality Assurance environment (medical devices preferred).
• Strong communication and project management skills.
• Proficiency in Microsoft Office and statistical analysis tools (e.g., Minitab).
• Ability to work independently and make sound decisions.

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