Idania A. Profile

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$25 USD / hour

toulouse,

france

$25 USD / hour

It's currently 8:49 AM here

Joined July 30, 2017

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Idania A.

@idaniaar

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(0 reviews)

0.0

$25 USD / hour

toulouse,

france

$25 USD / hour

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Quality and Project Management

Hi. Thanks for coming! Please let me present myself: Solution-focused compliance/project engineer experienced in new products configuration/validation of codes as per client requirement and conducting investigation (CAPA) to ensure compliance with customer needs. In addition, skills on Failure Mode and Effect Analysis (FMEA), Solving Problem Tools, Audit ISO13485-2003 & CAPA Lead Investigator. Let's reach our goal together!

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Experience

Medtronic

Jan 2017 - Sep 2018 (1 year, 8 months)

1. Coordinate Internal Audits. 2. Create/design and validate new product configuration per customer requirements ensuring quality throughout the product development and monthly revenue to the company. 3. Review post-validation changes (Change Control/CDPs/ECOs/SCOs/MCOs) guarantying the accuracy of what is being documented (according to the operational procedures), consequently reducing the approval rejections. 4. Write operational procedures for continuous improvement purpose. 5. Execute a range of projects per estimated deadline, including process qualification (PQ), installation qualification (IQ) and operational qualification (OQ) and proper coordination with suppliers. 6. Execute the transfer validation process from one manufacturing site to another in accordance with the regulatory bodies.

Medtronic

Jan 2015 - Dec 2016 (1 year, 11 months)

1. Conduct CAPA (corrective action and preventive action) Investigation according to the scheduled timeline reducing quality issues and/or customer complaints in 30%. 2. Execute Field Technical Reports (Customer Complaints Analysis) through investigation and root cause analysis promoting process improvement and customer satisfaction. 3. Track CAPAs activities resulting in no-overdue implemented actions to meet company indicators. 4. Prepares project status reports by collecting, analyzing, and summarizing information and trends. 5. Provide efficient leadership of the multidisciplinary team.