Stellar Consulting Solutions, LLC
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Stellar Consulting Solutions, LLC provides a base pay range of $40.00/hr to $45.00/hr. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
The Quality Engineer supports new product development and ongoing product maintenance for medical devices. This role ensures that products meet quality and regulatory standards from concept through launch and lifecycle management. The position requires strong technical, analytical, and problem-solving skills, with a focus on design control, process validation, and continuous improvement.
Key Responsibilities
Apply quality engineering principles, tools, and methodologies to support product development and sustaining projects.
Ensure all design control and production activities comply with FDA, ISO, and corporate quality requirements.
Serve as the Quality representative on cross‑functional product teams.
Review and approve design and process specifications, test methods, and quality documentation.
Support or participate in internal and supplier quality audits (may serve as auditor‑in‑training).
Identify and implement process improvements to enhance product quality and compliance.
Education & Experience
Bachelor’s degree in Engineering, Science, or a related field.
Minimum 5 years of relevant experience in quality engineering or a regulated medical device environment (or equivalent education and experience).
Knowledge & Skills
Working knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO standards (13485, 14971, MDSAP, EU MDR/IVDR).
Experience with quality tools and methods, including risk management, CAPA, root cause analysis, process validation, software validation, statistical methods (SPC, DOE, capability analysis, sampling plans), measurement systems analysis, test method validation, and process mapping/continuous improvement tools (Pareto, histograms, etc.).
Familiarity with electronic Quality Systems (e.g., TrackWise or similar) preferred.
Preferred Attributes
Certification in Quality Engineering (CQE) or related field a plus.
Demonstrated ability to work collaboratively across functions.
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Stellar Consulting Solutions, LLC provides a base pay range of $40.00/hr to $45.00/hr. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
The Quality Engineer supports new product development and ongoing product maintenance for medical devices. This role ensures that products meet quality and regulatory standards from concept through launch and lifecycle management. The position requires strong technical, analytical, and problem-solving skills, with a focus on design control, process validation, and continuous improvement.
Key Responsibilities
Apply quality engineering principles, tools, and methodologies to support product development and sustaining projects.
Ensure all design control and production activities comply with FDA, ISO, and corporate quality requirements.
Serve as the Quality representative on cross‑functional product teams.
Review and approve design and process specifications, test methods, and quality documentation.
Support or participate in internal and supplier quality audits (may serve as auditor‑in‑training).
Identify and implement process improvements to enhance product quality and compliance.
Education & Experience
Bachelor’s degree in Engineering, Science, or a related field.
Minimum 5 years of relevant experience in quality engineering or a regulated medical device environment (or equivalent education and experience).
Knowledge & Skills
Working knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO standards (13485, 14971, MDSAP, EU MDR/IVDR).
Experience with quality tools and methods, including risk management, CAPA, root cause analysis, process validation, software validation, statistical methods (SPC, DOE, capability analysis, sampling plans), measurement systems analysis, test method validation, and process mapping/continuous improvement tools (Pareto, histograms, etc.).
Familiarity with electronic Quality Systems (e.g., TrackWise or similar) preferred.
Preferred Attributes
Certification in Quality Engineering (CQE) or related field a plus.
Demonstrated ability to work collaboratively across functions.
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