Sr Quality Engineer

Artech LLC

Louisville, CO

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JOB DETAILS

SALARY

$55–$60 Per Hour

SKILLS

Communication Skills, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Document Control, Document Management, Documentation, Establish Priorities, FDA (Food and Drug Administration), Healthcare Quality, ISO (International Organization for Standardization), Manufacturing, Medical Equipment, Operations Management, Procedure Development, Process Improvement, Quality Engineering, Regulatory Compliance, Risk Analysis, Risk Management, Statistics, Team Player, Testing, Validation Documentation

LOCATION

Louisville, CO

POSTED

1 day ago

Job Title: Sr. Quality Engineer
Job ID: 26546
Duration: 6 months
Location: 1480 Arthur Ave, Unit D, Louisville Colorado 80027
Pay Range: $55-60.00/hr. on W2

Key Responsibilities:

Review/approve Non-Conformances (NCMRs), Document Changes, and Validation documents.
Perform QMS harmonization by aligning local procedures with enterprise QMS requirements.
Review/write technical procedures and update controlled documents.
Lead Gemba Walks, identify risks, and drive corrective actions.
Support CAPA, quality documentation, inspections, testing, statistical analysis, process improvements, and regulatory compliance.
Collaborate with Engineering and Manufacturing while managing both daily operational tasks and long-term projects.

Required Skills:

Technical procedure review & writing.
Strong knowledge of FDA, ISO 13485, and NCMR requirements.
Experience with QMS/document control, validations, CAPA, risk management, and quality systems.
Ability to prioritize multiple assignments and work independently.
Strong communication and cross-functional collaboration skills.

Education: B.S. in Engineering
Experience: 7–10 years in Medical Device Quality Engineering
Work Schedule: 40 hrs/week, 100% Onsite

Sr Quality Engineer

Artech LLC

Louisville, CO

About the Company

Artech LLC

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