Quality Assurance Specialist
Current• Ensure appropriate policies and procedures comply with ISO13485:2016 standard. • Collaborate for all Department process efficiency by giving advice and support. • Ensure the incoming and process inspections are conducted on items/products according. • Plan and ensure product audits and internal audits are performed, documented, and reported. • Define PPAP levels and conduct PPAP evaluations and approvals. • Manage supplier non-conformance and supplier notification. Issue, evaluate, and approve supplier correction action requests. • Perform / support supplier risk assessments and supplier evaluations. • Perform supplier audits according to global head office requests. • Monitor and analyze customer complaints/claims related to the product and process. • Manage KPIs for the defined area. • Provide monthly management reports regarding complaints trending, CAPA's, Internal audits, etc. • Maintain relationships with global Invacare Quality departments regarding product issues. • Provide support to the Regulatory and Affairs Department. • Drive/support development and improvement on relater quality processes.