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Quality Engineer

Job in Cleveland, Cuyahoga County, Ohio, 44101, USA
Listing for: Katalyst CRO
Full Time position
Listed on 2025-12-01
Job specializations:
  • Quality Assurance - QA/QC
    Quality Engineering, Quality Control / Manager, QA Specialist / Manager
  • Engineering
    Quality Engineering, QA Specialist / Manager
Job Description & How to Apply Below

Overview

2 days ago Be among the first 25 applicants

Responsibilities
  • Develop and implement product and process quality control plans.
  • Lead investigations of customer complaints, returns, and nonconformances.
  • Conduct inspections, First Article and PPAP submissions, and support audits.
  • Administer corrective and preventive actions (CAPA) and verify effectiveness.
  • Use data-driven methods (SPC, Six Sigma) to identify and implement improvements.
  • Partner with internal and external stakeholders to meet quality and compliance goals.
Requirements
  • Bachelor's degree in engineering required.
  • 35 years' experience in quality engineering or manufacturing.
  • Knowledge of ISO 9001:2015 (auditing experience required).
  • Familiarity with IPC 620; AS9100 or ISO 13485 experience a plus.
  • Strong skills in root cause analysis, CAPA, and statistical tools.
  • ERP/MRP and Microsoft Office proficiency.
  • Preferred: ASQ CQE, Internal Auditor certification, industry experience in aerospace, military, or medical devices.
Required Skills/Abilities
  • Strong analytical and problem-solving skills with attention to detail.
  • Excellent verbal and written communication, including technical reporting.
  • Ability to interpret engineering drawings and technical documentation.
  • Effective project and time management skills with ability to handle multiple priorities.
  • Skilled at cross-functional collaboration and influencing teams toward quality objectives.
  • Ability to work independently and lead investigations with minimal oversight.
Seniority Level

Associate

Employment Type

Contract

Job Function

Quality Assurance

Industries

Pharmaceutical Manufacturing

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