San Diego, CA30+ days ago
Knowledge and Skills: • Quality Management Systems requirements for medical devices • Knowledge and applied experience of 21CFR, MDD 93/42/EEC, MDR 2017/745, ISO13485, and ISO14971 • Quality system auditing • Management of FDA and notified body audits • Risk Management • Change control • Software Validation • Test method validations • Post Market Surveillance • Statistical Analysis • CAPA - Root cause investigation and implementation of corrective/ preventive actions • Excellent oral and written communication skills, assertiveness skills • Good written and oral communication • Cross functional team collaboration and influencing • Critical thinking and analytical skills. • Ensure compliance of the San Diego Design Center QMS, maintain effectiveness of the internal audit program, coordinate external audits and ensure that Design center sites are ready to manage external audits.