The Quality Engineer II will manage the Internal Audit Program, train employees as Internal Auditors, and handle failure investigations, CAPA follow-ups, supplier qualifications, and validation support. They will generate reports on key metrics (complaints, non-conformances, deviations, CAPAs) to drive quality improvements, reduce defects, and enhance efficiency.

Pay: $75k-100k/yr

Job Responsibilities:

• Lead Continuous Improvement Projects focusing on quality processes in manufacturing and production.
• Create, revise, and maintain SOPs as needed.
• Conduct Process Failure Mode and Effect Analysis, investigations, and define CAPAs to prevent future issues.
• Support validation efforts (IOQ/PQ/CS) when needed.
• Diagnose and correct improper quality practices with guidance from Quality Managers.
• Assist with internal audits and provide training for others to conduct area audits.
• Maintain the CAPA program.
• Track and analyze data to recommend improvement projects that reduce costs, defects, and inform business decisions.
• Other duties as assigned.

Qualifications:

• BS in Engineering or related field.  
• Experience with manufacturing, quality systems, and data analytics.
• 3+ years in a GMP-regulated environment (preferably 21 CFR 210/211, CAPA, validation).
• Bachelor’s degree in Engineering or related field (or equivalent experience).
• Familiar with Microsoft Office, ERP/MRP systems, Minitab.
• Continuous improvement experience required.

Physical Requirements:

• Ability to lift 25+ lbs and stand/walk for extended periods.
• Some travel (<10%).
• Use of safety equipment in certain areas.
• Ability to bend, push, pull, reach, and climb stairs.

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