Senior Quality Engineer

Indotronix Avani Group provided pay range

This range is provided by Indotronix Avani Group. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$50.00/hr - $50.00/hr

Job Title: Sr. Quality Analyst/Engineer

Duration: 6+ months

Location: Madison, WI 53718

Develop and maintain quality system processes, including metrics reporting and tracking. Manage CAPA initiation, review, surveillance, and reporting. Facilitate the site Quality Management reviews. Facilitate and lead the site Change Management process. Support and lead root cause analyses through cross-functional team involvement. Leading Good Documentation Practice training and Quality on the Floor coordination and performance. Interpret and properly apply all applicable regulatory requirements.

Coordinate and provide direct support for facility audits by internal and external entities. Manage data collection and reporting when product recalls are required. Perform trending of Quality Systems to support FDA and Management reviews. Improve quality culture through site initiatives and improve existing procedures to better align with regulatory requirements. Review and approval of procedures, protocols, reports, etc., as required.

• Bachelor’s, or higher, degree in science/technology program preferred.
• 5+ years of Quality Assurance experience in a cGMP Quality Assurance/Compliant environment (medical devices preferred).
• Ability to utilize statistics at a moderate level for trending and interpretation of statistical data.
• Proficient with Microsoft Office tools, especially Excel, Word and PowerPoint.
• Technical writing.
• Statistical analysis – Minitab or other software equivalent, preferred.

• Associate

• Contract

• Quality Assurance

• Medical Equipment Manufacturing
• Pharmaceutical Manufacturing
• Biotechnology Research

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