Freelancer profile translated to English.

Description

Industrial and automation electronics engineer with more than 10 years of experience as a Quality Engineer and Head of Regulatory Affairs in different sectors; mainly in manufacturers and importers of healthcare products.

I bring experience in Quality Management of different types of products and industries such as:

- Healthcare products

- Official protection equipment

- Cosmetic products

- Textiles

- Materials in contact with food

- Packaging

Implementation of Quality Management System under ISO 9001, ISO 13485 and ISO 14001 standards.

Certification as Lead Auditor: ISO 9001:2015

Standards: ISO 9001, ISO 13485, ISO 14001, ISO 17020, BRC

Industry field of expertise

Languages

English
Fluent
German
Basic
Spanish
Native or bilingual

Workplace preferences

Can work on-site

Madrid (up to 15km)

MM Packaging
Quality Engineer
June 2024 - Today (2 years)
Quality Engineer

Implementation and management of QMS.
Management of NC, CAPAs and Audits.

Transposition of global group policies.
Insulcloud
Head of Quality and Regulatory Affairs
BIOTECH
January 2024 - June 2024 (5 months)
Head of Quality and Regulatory Affairs for Class IIa and IIb Healthcare Products. Product registration under MDR Regulation and ISO 13485 certification.
Avizor
Head of Regulatory Affairs - APAC
January 2023 - January 2024 (1 year)
Head of Regulatory Affairs for the APAC region.

Registration of healthcare products in the countries of the region (China, Vietnam, Australia, Indonesia, Taiwan, etc.)