Quality Assurance Specialist

hace 4 semanas


Paraíso, Paraíso, Costa Rica Coloplast A tiempo completo

Job Summary

We are seeking a Quality Assurance Specialist to ensure compliance to external and internal quality requirements and provide support to Operations value stream in accordance with Coloplast Quality Management System.

Main Responsibilities

Create and maintain quality related documentation, including Device Master Record, Quality plan, Control plan, Quality record, and local quality instructions.

Ensure quality approval and release of products, handle non-conforming products, and control returned goods.

Handle CAPA initiations, root cause investigations, and evaluation of effectiveness, as well as quality related change request tasks in projects.

Distribute product drawings to production, support Head of Quality in data gathering for Quality Management Reviews, and participate in internal and external audits.

Requirements

Bachelor's degree in Industrial Engineering, Quality, Production, Chemistry, or equivalent.

Minimum 2 years of experience in medical device or manufacturing industry with thorough knowledge of quality assurance methodologies and standards.

Minimum 3 years of experience in Quality related roles, knowledge of statistical/data analysis, and report writing experience.

Experience with control of nonconforming material, corrective and preventive actions, and Microsoft office package, E1, TrackWise, Meridian, Cognos, SharePoint.

English (minimum B1 level) reading, writing, and speaking in a conversational level.

About Coloplast

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs.

We are one of the world's leading medical device companies, employing about 16,000 people and with products available in more than 143 countries.



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