Description:
· Quality Compliance and Audits: Ensure quality compliance for medical devices and combination products, conducting and supervising audits of GCP, GLP, GMP suppliers, and service providers.
· Policy and Procedure Implementation: Develop and implement quality policies, procedures, training, controls, and corrective/preventive actions, maintaining compliance with federal and international regulations.
· Quality Investigations and QMS Management: Lead quality investigations, manage QMS metrics (Issue/Deviation, CAPA, SCAR, Change Control), and oversee effective production processes and product specifications.
· Regulatory Readiness and Records Review: Manage registration readiness for ISO and CE marking, oversee the review and approval of quality records (Clinical Study Reports, Device History Records, OOS reports, audit reports), and ensure vendor and supplier compliance.
· Final Product and Clinical Supplies Disposition: Conduct final product lot and clinical trial supplies disposition activities, ensuring adherence to cGMPs, company SOPs, policies, and specifications, and manage oversight of change controls and stability protocols.
Job Type: Contract
Pay: $65.00 - $100.00 per hour
Expected hours: 40 per week
Schedule:
Experience:
- Quality Assurance: 10 years (Required)
- Quality Assurance manager: 5 years (Required)
- Clinical Quality: 10 years (Required)
- medical devices Industry: 10 years (Required)
- Combination devices: 5 years (Required)
- GCP AUDITS: 10 years (Required)
Work Location: Remote