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Quality Engineer

Job in Elkhart, Elkhart County, Indiana, 46516, USA
Listing for: Katalyst CRO
Full Time position
Listed on 2025-10-31
Job specializations:
  • Engineering
    Quality Engineering, Process Engineer
  • Quality Assurance - QA/QC
    Quality Engineering
Salary/Wage Range or Industry Benchmark: 60000 - 80000 USD Yearly USD 60000.00 80000.00 YEAR
Job Description & How to Apply Below

Join to apply for the Quality Engineer role at Katalyst CRO

Responsibilities
  • Develop, implement, and maintain quality systems to ensure compliance with industry standards and customer requirements.
  • Collaborate with engineering and production teams to establish and monitor quality control processes.
  • Support new product introductions by developing inspection plans, test protocols, and validation activities.
  • Perform root cause analysis and lead corrective and preventive action (CAPA) initiatives.
  • Conduct audits of processes, products, and suppliers to verify adherence to quality standards.
  • Analyse data, track metrics, and generate reports to drive continuous improvement.
  • Train and support production staff in quality standards, documentation, and best practices.
  • Partner with supply chain and operations to ensure incoming materials meet specifications.
  • Identify opportunities to improve efficiency, consistency, and product reliability.
Requirements
  • Bachelor's degree in quality, Manufacturing, Mechanical, or Industrial Engineering (or related field).
  • 5+ years of experience in a quality engineering role (medical device or precision manufacturing preferred).
  • Knowledge of quality management systems (ISO 13485, ISO 9001, or equivalent).
  • Familiarity with FDA regulations and medical device compliance is a plus.
  • Experience with root cause analysis, FMEA, SPC, and CAPA methodologies.
  • Strong understanding of inspection methods, measurement systems, and GD&T.
  • Proficiency with ERP/MRP systems, statistical analysis tools, and Microsoft Office.
  • Excellent communication, problem-solving, and cross-functional collaboration skills.
Seniorities
  • Mid-Senior level
Employment type
  • Contract
Job function
  • Quality Assurance
  • Industries:
    Pharmaceutical Manufacturing
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