Quality Engineer - Pharma CAPA & Compliance Investigator

Biopharma Careers; Bronx (ID); On-site; USD 85,000 - 125,000; Full time

Job summary

Perrigo is seeking a Quality Engineer to assist investigations and documentation of quality-related complaints and regulatory inquiries for Perrigo drug and device products. You will independently scope and lead investigations for customer complaints, support CAPA tracking, and contribute to supplier qualification programs.

The role emphasizes cGMP knowledge, data analysis, and collaboration across functions.

Qualifications

• Bachelor's degree in science, engineering, or technical discipline required.
• Solid understanding of quality engineering principles and practices.
• Experience in pharmaceutical manufacturing, QA/QC, inspections, or R&D preferred.

Responsibilities

• Lead investigations related to customer complaints and regulatory inquiries.
• Support CAPA management system: track actions, verify corrections, evaluate effectiveness.
• Assist supplier qualification and assessment program for new and existing material suppliers.
• Maintain and report supplier performance metrics and scorecards.
• Support APR process by preparing reports and coordinating follow-ups.
• Identify and implement risk mitigation plans; conduct for-cause supplier assessments when needed.

Skills

Quality Engineering

cGMP

FDA regulations

Analytical troubleshooting

Regulatory compliance

Communication skills

Education

Bachelor's degree in a scientific, engineering, or technical discipline

Tools

TrackWise

SAP

Microsoft Office

Job description

Perrigo is seeking a Quality Engineer to assist investigations and documentation of quality-related complaints and regulatory inquiries for Perrigo drug and device products. You will independently scope and lead investigations for customer complaints, support CAPA tracking, and contribute to supplier qualification programs.

The role emphasizes cGMP knowledge, data analysis, and collaboration across functions.