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.
- 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 (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.
- Assist 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.
