Provide quality and manufacturing support for production operations, supplier quality, validation, and process improvement initiatives. This role will assist with manufacturing transfers, quality system compliance, and continuous improvement efforts within a regulated production environment.
2+ years of experience in Manufacturing Quality, Quality Assurance, Supplier Quality, Process Quality, or Validation.
Hands-on experience with CAPA, NCRs, quality documentation, inspections, and audit support.
Familiarity with manufacturing quality systems, process validation, and regulated production environments.
Strong documentation, organizational, and problem-solving skills.
Preferred Qualifications:
Experience in the medical device or other regulated manufacturing industry.
Exposure to manufacturing transfers, process validation, supplier quality, or new product introduction (NPI) activities.
Experience with respiratory care, ventilator, CPAP, sleep therapy, or similar healthcare products is a plus.
Support daily manufacturing quality activities and ensure compliance with established quality standards.
Assist with process validation, verification activities, and production readiness initiatives.
Perform inspections, maintain quality documentation, and support process monitoring activities.
Participate in CAPA, Non-Conformance (NCR), deviation investigations, and corrective action tracking.
Collaborate with Supplier Quality, Manufacturing Engineering, and Production teams to resolve quality issues and support ongoing manufacturing operations.
Collect, analyze, and document quality metrics, validation results, and production data.
Assist with internal audits, compliance initiatives, and continuous improvement projects.
Support manufacturing process transfers, equipment qualifications, and product transition activities.
Numbers & Facts
Location
new kensington, PA
Skills
Analysis Skillsunmatched
Continuous Improvementunmatched
Corrective Actionunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Documentationunmatched
Healthcareunmatched
Internal Auditunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Manufacturing Engineeringunmatched
Manufacturing Operationsunmatched
Manufacturing Systemsunmatched
Manufacturing/Industrial Processesunmatched
Medical Equipmentunmatched
Operational Supportunmatched
Problem Solving Skillsunmatched
Process Improvementunmatched
Process Qualityunmatched
Process Validationunmatched
Product/Service Launchunmatched
Production Supportunmatched
Production Systemsunmatched
Quality Assuranceunmatched
Quality Engineeringunmatched
Quality Managementunmatched
Quality Metricsunmatched
Respiratory Medicineunmatched
Respiratory Therapyunmatched
Support Documentationunmatched
System Validationunmatched
Validation Testingunmatched
Ventilatorunmatched
🎯
Be found by employers
5,500+ employers search our resume database daily. Add yours to get found by recruiters looking for candidates like you.
Level up your application
Professional resume templates
Browse dozens of recruiter approved resume templates, layouts and formats. Choose your favorite and make it your own in minutes.