Quality Lead
clindcastEastern, KY
Quality Lead
clindcastEastern, KY
yesterday
Industries
Surgical Appliance and Supplies ManufacturingElectromedical and Electrotherapeutic Apparatus ManufacturingSurgical and Medical Instrument ManufacturingAbout the role
Seeking a Quality Lead to support quality remediation and compliance initiatives within the medical device industry. The role will manage CAPA, nonconformance, deviations, complaints, quality systems, root cause investigations, and quality improvement activities while ensuring regulatory compliance.
Key Responsibilities:
Manage CAPA, Nonconformance, Deviation, and Complaint activities.
Conduct Root Cause Analysis and implement corrective actions.
Analyze quality metrics and identify recurring issues/trends.
Support quality audits and FDA readiness initiatives.
Collaborate with cross-functional teams on quality improvements.
Required Skills:
CAPA, Nonconformance, and Deviation Management.
Root Cause Analysis: 5 Why, Fishbone, FTA.
Quality Metrics and Trend Analysis.
Knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
Design Controls and Validation Support.
Preferred Qualifications:
Bachelor's degree in Engineering or related discipline.
8+ years of Medical Device Quality experience.
Experience with Class II/III medical devices.
Experience supporting FDA, MDSAP, and ISO audits.
ClinDCast offers Healthcare IT solutions and consulting services to payers, providers and life sciences organizations enabling them to enhance care delivery to patients.
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JOB OVERVIEW
Experience level
Manager
Location
Eastern, KY
Occupation
Quality Control Systems Managers
Industry
Surgical Appliance and Supplies Manufacturing
Posted
yesterday
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