Talnt · 23 hours ago
Quality Process Engineer (bilingual)
Minneapolis, Minnesota, United States
Full-time
Onsite
Mid Level
3+ years expTalnt is a company focused on quality excellence within manufacturing operations. The Quality Process Engineer is responsible for improving production processes and quality systems, ensuring compliance with regulatory requirements and internal quality objectives.
Staffing & Recruiting
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
Qualification
Required
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
Preferred
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
Company
Talnt
Talnt uses AI and automation to identify and qualify candidates quickly.
2-10 employees
Funding
Current Stage
Early StageLeadership Team
Emmet Nitto
Founder
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