Erika Gonzalezz

Passionate about continuous improvement and problem-solving methodology, always thinking about quality, taking care of resources and focused on results.
Several years of experience in the medical device industry. Demonstrated ability in quality systems and operations, manufacturing processes, customer complaints management, failure investigations, CAPAs, system and product transfer, as well as support to FDA internal and external audits. Problem solving methodology, kaizen, cost reduction, six sigma, continuous improvement. According to the regulatory requirements of ISO: 13485.

● Provided support in transfers of new product introduction.

● Lead, reviewed and approved non-conformances investigations and product disposition.
● Lead CAPA investigations.
● Performed complaint analysis and failure investigations for different product families.
● Collaborate in the review and maintenance of PFMEAs, Quality control plans and process instruction.
● Defined and executed project plans to solve product/quality issues at the plant or franchise level.
● Provided support on internal and external audits (FDA, JJRC, BSI, MDSAP).
● Responded to internal and external audits observations related to quality system process.
● Provided support in the review of IQ, OQ, PQ validation activities.
● Lead the follow-up of customer complaints.

● Made changes to engineering documents.

● Lead and collaborate in Kaizen and Problem solving events and trainings.

Universidad TecMilenio 2018 – 2020
B.S. in Industrial engineering & manufacturing systems.

Green Belt by SigmaPro. 

Universidad Tecnológica de Ciudad Juárez 2014 – 2017
Industrial engineering & manufacturing systems TSU.

Intermediate English (Currently at Quick Learning)