Quality Systems Lead

Sigmar Recruitment

Sligo

What You Will Do: Ensureadherence all site ISO certification and Regulatory Status including ISO 13485. Provide Quality Support to all departments. Lead and champion the site audit readiness program. Perform CAPA activities, as required in addition to the investigation of root cause analysis, CAPA generation and effectiveness monitoring. Support the transfer of products and processes from development through to production on site. What You Will Need: Degree in Science/Engineering/Quality with a Green Belt in Lean Six Sigma. Minimum 5 year's within Medical Device or manufacturing industry. Must have expert knowledge of Regulations, ISO13485, MDD, FDA CFRs, Medical Device Standards. Experience of Internal and External Audits & have a qualification in Auditing.

1112 days ago