Quality Engineer

18 hours ago

Eagan, United States Cypress HCM Full time

A Health, Beauty and Cosmetic Manufacturing Client is looking for a direct hire, Quality Engineer onsite in Eagan, Minnesota. The objective of this role is to improve quality within production to meet our customer’s needs and expectations. This Quality Engineer will focus on process and equipment improvements, develop quality control systems and processes, and attack quality system failures using effective root cause analysis methods. Additionally, this role will concentrate on continuous improvement through the implementation of effective Corrective and Preventive Actions (CAPA). The Quality Engineer will play a key role in ensuring that products meet industry standards, regulatory requirements, and internal quality objectives, while promoting a culture of compliance and continuous improvement across the organization.


Responsibilities

  • Lead quality-related problem-solving and root cause analysis in manufacturing to prevent recurrences.
  • Lead process validation, equipment qualification, and cleaning validation activities.
  • Participate in the investigation of technical issues, status of testing, and the establishment of procedures and CAPA to ensure product quality and regulatory compliance.
  • Operate independently, representing the quality organization in major meetings to resolve key issues and plan work.
  • Coordinate cross-functional teams to address Non-Conformance issues to reduce scrap and improve First Pass Yield (FPY).
  • Identify and analyze quality problems in production and testing, leading the problem-solving process to root cause determination and evaluating the effectiveness of implemented actions.
  • Work with internal teams and customers to identify and develop key quality metrics and ensure systematic analysis of quality data to drive improvements.
  • Update and write SOPs validation protocols, conduct internal audits and support Supplier Qualification process.
  • Ensure compliance with company policies, procedures, and quality standards, including Good Manufacturing Practices (cGMP), safety, and environmental regulations.
  • Participate in safety, GMP, and other company-required training sessions.


Requirements

  • Bachelor’s degree in Engineering (Master’s degree preferred).
  • 3-5 years of experience in cosmetics, medical device, or pharmaceuticals with a Bachelor’s degree, or 1-2 years with a Master’s degree.
  • Strong knowledge of quality systems (ISO 9001, GMP, FDA regulations), personal care industry standards, and regulatory compliance.
  • Strong knowledge of quality assurance methods, tools, and relevant manufacturing processes.
  • Experience with quality management software and systems (e.g., CAPA, FMEA, SPC).
  • Strong proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).


Preferred Education and Experience

  • Six Sigma Green or Black Belt
  • Certified Quality Engineer (CQE)
  • ISO 9001 Lead Auditor Certification
  • Bilingual in English and Spanish is a plus.


Flexible salary of $80 - 110K, depending one experience level, education, certs, etc.

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