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Manufacturing Quality Engineer

Katalyst Healthcares & Life Sciences

Omaha, NE

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JOB DETAILS
SKILLS
AS 9100, American Society for Quality (ASQ), Analysis Skills, Auditing, Biomedical Engineering, Certified Quality Engineer (CQE), Change Control, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Data Analysis, Documentation, Equipment Validation, Failure Mode and Effects Analysis (FMEA), GMP (Good Manufacturing Practices), GxP, ISO (International Organization for Standardization), ISO 9001, Internal Audit, Lean Manufacturing, Lean Six Sigma, Maintain Compliance, Manufacturing, Manufacturing Operations, Operational Support, Operations, Process Improvement, Process Validation, Quality Assurance, Quality Engineering, Quality Management, Quality Metrics, Regulations, Regulatory Compliance, Regulatory Requirements, Risk Management, Root Cause Analysis, Standard Operating Procedures (SOP), Statistical Process Control, Supply Chain Operations, Technical Writing
LOCATION
Omaha, NE
POSTED
2 days ago
Job Description:
We are seeking a Manufacturing Quality Engineer to support manufacturing operations by ensuring products meet quality standards, regulatory requirements, and customer expectations. The ideal candidate will drive quality improvements, investigate non-conformances, lead root cause analysis activities, and collaborate with cross-functional teams to maintain a robust Quality Management System (QMS).
Responsibilities:
  • Support daily manufacturing operations to ensure compliance with quality standards and procedures.
  • Investigate product defects, non-conformances, deviations, and customer complaints.
  • Lead root cause investigations using methodologies such as 5 Whys, Fishbone, Pareto Analysis, and FMEA.
  • Develop, implement, and monitor Corrective and Preventive Actions (CAPA).
  • Analyze quality metrics and identify opportunities for continuous improvement.
  • Review and approve manufacturing procedures, work instructions, SOPs, and quality documentation.
  • Support process validation, equipment qualification, and change control activities.
  • Conduct internal audits and participate in customer, regulatory, and certification audits.
  • Collaborate with Manufacturing, Engineering, Supply Chain, Operations, and Quality teams.
  • Monitor Statistical Process Control (SPC) data and implement process improvements.
  • Ensure compliance with applicable regulations and quality standards.
  • Support risk management and quality planning activities.

Requirements:

  • Bachelor's degree in mechanical, Industrial, Manufacturing, Biomedical Engineering.
  • 3+ years of experience in Quality Engineering, Manufacturing Quality, or Quality Assurance.
  • Experience in a manufacturing environment.

Required Skills:

  • Quality Management Systems (QMS).
  • CAPA Management.
  • Root Cause Analysis.
  • Non-Conformance Management.
  • Change Control.
  • Statistical Process Control (SPC).
  • FMEA (Failure Mode and Effects Analysis).
  • Risk Management.
  • Process Improvement.
  • Data Analysis and Reporting.
  • Technical Documentation.

Preferred Qualifications:

  • Experience with:
    • ISO 9001
    • ISO 13485
    • AS9100
    • IATF 16949
    • GMP/GxP environments
  • Knowledge of Lean Manufacturing and Six Sigma methodologies.
  • Experience with validation and qualification activities.
  • ASQ certifications such as American Society for Quality CQE or CQA preferred.

 

About the Company

K

Katalyst Healthcares & Life Sciences

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