Overview
Remote
On-site
Job Description
Summary:An opportunity is available for an experienced Quality Engineer to support quality systems, investigations, compliance, and continuous improvement within a regulated medical-device manufacturing environment.Roles & Responsibilities:
- Manage and investigate nonconforming materials, products and processes
- Support the complete CAPA lifecycle, including investigation, documentation and effectiveness activities
- Conduct structured Root Cause Analysis (RCA) and problem-solving
- Maintain compliance with established Quality Management System requirements
- Support compliance with ISO 13485 and FDA 21 CFR Part 820 / QMSR requirements
- Identify and implement quality and manufacturing process improvements
- Apply Lean Manufacturing and Six Sigma methodologies to reduce defects and improve operational performance
- Support inspection-ready documentation and quality records
- Collaborate with manufacturing, engineering and other cross-functional teams to resolve quality issues
Qualification:
- Medical-device industry experience is mandatory
- CAPA and Nonconformance Management experience
- Quality investigations and Root Cause Analysis
- Strong Quality Management Systems knowledge
- ISO 13485 experience
- FDA QMSR / 21 CFR Part 820 knowledge
- Continuous improvement and process-improvement experience
- Lean Manufacturing / Six Sigma knowledge
- Experience working within highly regulated manufacturing environments
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FAQs About Quality Engineer Jobs at Katalyst Healthcares & Life Sciences
What is the work location for this position at Katalyst Healthcares & Life Sciences?
This job at Katalyst Healthcares & Life Sciences is located in Salt Lake City, UT, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Katalyst Healthcares & Life Sciences?
Employer has not shared pay details for this role.
What employment applies to this position at Katalyst Healthcares & Life Sciences?
The employer has not provided this information. This may be discussed during the hiring process.
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