Sustaining Manufacturing / Quality Engineer

Job Title: Sustaining Manufacturing / Quality Engineer

Pay Rate: $52 to $58.27/HR

Duration: 24 months

Location: Draper, UT (Onsite)

We are looking for a Sustaining Manufacturing / Quality Engineer to support ongoing manufacturing operations by investigating production issues, driving continuous improvements, and ensuring compliance with quality and regulatory standards. This role focuses on root cause investigations, non-conformance management, corrective and preventive actions (CAPA), and statistical analysis to improve manufacturing processes. The ideal candidate is a self-motivated engineer with experience in regulated manufacturing environments such as Medical Devices, Aerospace, or Automotive.

• Support sustaining engineering activities for existing manufacturing processes and products.
• Lead investigations into manufacturing issues, product defects, and process non-conformances.
• Perform root cause analysis using structured problem-solving methodologies (5 Whys, Fishbone, DMAIC, etc.).
• Drive corrective and preventive actions (CAPA) to resolve quality issues and prevent recurrence.
• Review engineering protocols, validation documentation, and technical reports for accuracy and compliance.
• Utilize Minitab to perform statistical analyses including regression analysis, t-tests, capability studies, and trend analysis.
• Analyze manufacturing data to identify process improvements and reduce variability.
• Collaborate with cross-functional teams including Manufacturing, Quality, R&D, and Regulatory Affairs.
• Ensure manufacturing processes comply with ISO 13485, FDA regulations, and internal quality standards.
• Support continuous improvement initiatives using Lean Manufacturing and Six Sigma methodologies.
• Document investigations, technical findings, and engineering recommendations in accordance with quality system requirements.

Requirements:

• Bachelor's degree in engineering required.
• Minimum 2 years of engineering experience in a manufacturing environment.
• Experience performing root cause analysis and leading problem-solving activities.
• Hands-on experience with non-conformance investigations, corrective actions, and quality improvement initiatives.
• Working knowledge of Minitab and statistical analysis techniques such as:
• Regression Analysis
• T-Test
• Statistical Process Analysis
• Experience working within regulated manufacturing environments.
• Strong written and verbal communication skills.
• Ability to work independently with minimal supervision.
• Self-motivated and proactive approach to problem solving.

Preferred Qualifications

• Experience in Medical Device, Aerospace, or Automotive industries.
• Working knowledge of:
• ISO 13485
• FDA Quality System Regulations (21 CFR Part 820/QMS)
• ASQ Certification (CQE, CQA, or equivalent).
• Lean Six Sigma Green Belt or Black Belt certification.
• Experience supporting sustaining engineering or manufacturing quality functions.