More jobs:
Quality Engineer
Job in
Elkhart, Elkhart County, Indiana, 46516, USA
Listed on 2025-10-31
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
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.
- 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.
- Mid-Senior level
- Contract
- Quality Assurance
- Industries:
Pharmaceutical Manufacturing
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