Antonio Andrada

- Full product validations according ISO standard and MDD -Technical File -Projects Leader -Employees Managing (10 people) - Training -CAPA system -NB audits -Customer Complaints

• Implementing Medical Devices MDD93/42/CEE and harmonized standard with it • Implementing quality system based in UNE-EN ISO 13485 • Technical file for Class I sterile and IIa products (including Risk Management, Essential Requirements, Clinical Data) • CAPA system and Non Conformities management • Notified Body Audits Responsible • Internal Audits • Customers Complaints • Employees training

• Employees training • Procedures and Work Instructions writing and implementing • Non Conformities developing and root cause analysis • Performing corrective and preventive actions raised in Non Conformities

Processes and Production Planning Engineer carrying out duties and responsibilities like: -Production Planning and following up -Process control. Root cause analysis

Study of phenol oxidation in a load reactor