Quality Lead With Medical Device
talent groupsReedsville, PA
Quality Lead With Medical Device
talent groupsReedsville, PA
yesterday
Industries
Surgical Appliance and Supplies ManufacturingElectromedical and Electrotherapeutic Apparatus ManufacturingSurgical and Medical Instrument ManufacturingAbout the role
Support quality remediation and compliance initiatives by managing nonconformance, CAPA, deviation, complaint handling, and quality system activities. Perform quality assessments, root cause investigations, data analysis, and quality improvement initiatives while ensuring compliance with medical device regulations and standards
Key Responsibilities:
Manage CAPA, Nonconformance, and Deviation activities.
Conduct Root Cause Analysis and corrective actions.
Review quality metrics and identify recurring issues.
Support quality audits and FDA readiness programs.
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.
FDA 21 CFR Part 820, ISO 13485, ISO 14971.
Design Controls and Validation Support
Preferred Qualifications:
Bachelor's degree in Engineering discipline.
8+ years of Medical Device Quality experience.
Experience with Class II/III medical devices.
Experience supporting FDA, MDSAP, and ISO audits
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JOB OVERVIEW
Experience level
Manager
Location
Reedsville, PA
Occupation
Quality Control Systems Managers
Industry
Surgical Appliance and Supplies Manufacturing
Posted
yesterday
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