Quality Process Engineer (bilingual)

Quality Process Engineer (bilingual)

Minneapolis, Minnesota, United States

About the Role

The Quality Process Engineer, also commonly searched as Process Quality Engineer or Manufacturing Quality Engineer, is responsible for driving quality excellence within manufacturingoperations. This bilingual Spanish and English role focuses on improving production processes, equipment performance, and quality systems to ensure products meet customer expectations, regulatory requirements, and internal quality objectives. The position emphasizes continuous improvement, root cause analysis, CAPA implementation, and the development of bilingual manufacturing documentation while promoting a strong culture of compliance, safety, and quality.

Responsibilities

• Lead the bilingual Spanish and English development, review, and maintenance of manufacturing and packaging batch records.
• Drive quality improvement initiatives within production through process optimization and equipment performance enhancements.
• Conduct root cause analysis using structured problem-solving methodologies to identify and eliminate quality system failures.
• Support and execute process validation, equipment qualification, and cleaning validation activities in regulated manufacturing environments.
• Develop, implement, and monitor effective Corrective and Preventive Actions to prevent recurrence of quality issues.
• Investigate production and testing deviations, document findings, and establish compliant procedures aligned with GMP requirements.
• Represent the quality organization in cross-functional meetings, independently resolving complex quality and manufacturing issues.
• Write, revise, and maintain bilingual SOPs, validation protocols, and quality documentation, and perform internal quality audits.
• Ensure ongoing compliance with current Good Manufacturing Practices, safety standards, environmental regulations, and quality policies.
• Train manufacturing personnel on quality procedures, manufacturing processes, and compliance requirements.

Qualifications

• Bachelors degree in Engineering or a related technical discipline.
• Three to five years of experience in pharmaceutical, cosmetic, personal care, or regulated manufacturing environments.
• Fluency in written and spoken English and Spanish, with experience producing bilingual technical documentation.
• Strong working knowledge of quality systems, including GMP, FDA regulations, ISO 9001, and industry compliance standards.
• Hands-on experience with CAPA, FMEA, statistical process control, and quality management systems.
• Proven experience developing manufacturing and packaging batch records, validation protocols, and qualification documentation.
• Excellent analytical, critical thinking, and problem-solving skills with a strong attention to detail.
• High ethical standards, professionalism, and the ability to work independently in a fast-paced, cross-functional environment.
• Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint.

Desired Qualifications

• Masters degree in Engineering or a related technical field.
• One to two years of industry experience in pharmaceuticals or cosmetics combined with an advanced degree.
• ASQ Certified Quality Engineer certification or similar quality certification.
• Experience supporting audits, inspections, and regulatory submissions in regulated manufacturing settings.
• Demonstrated success leading continuous improvement initiatives and cross-functional quality projects.