Job Description: 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. Responsibilities:
Support daily manufacturing quality activities and ensure compliance with established quality standards.
ssist with process validation, verification activities, and production readiness initiatives.
Perform inspections, maintain quality documentation, and support process monitoring activities.
Participate in CAPA, Non-Conformance (Client), 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.
ssist with internal audits, compliance initiatives, and continuous improvement projects.
Support manufacturing process transfers, equipment qualifications, and product transition activities.
Requirements:
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.