QA Engineer - Provincia de Cartago, Costa Rica - Coloplast

Coloplast

Empresa verificada

Provincia de Cartago, Costa Rica

hace 1 semana

Publicado por:

Andrea Rodríguez

beBee Recruiter

Descripción

Location:

Cartago, Costa Rica, CR

Job Family:
Quality Assurance

Country/Region:
Costa Rica

Job function summary

The Quality Engineer ensures compliance to external and internal quality requirements and provides support to Operations value stream in accordance with Coloplast Quality Management System.

Major areas of accountability

Create and maintain quality related documentation e.g., Device Master Record, Quality plan, Control plan, Quality record, local quality instructions
Quality approval and release of products
Handle nonconforming products incl. control of returned goods incl. handling and reporting in TrackWise and handling of lot status in E
Handling of CAPA (initiations, root cause investigations and evaluation of effectiveness)
Handling of Quality related change request tasks in the projects through Change Control procedure
Distribute product drawings to the production
Support Head of Quality in data gathering for Quality Management Reviews
Support implementation of new machines and Item transfers with quality related tasks
Participate in both internal and external audits
Implementation, training and follow up in relation to continuous improvements, including participation in RCA.
Provide sparring and support to Global Operations incl. Global Quality and help improve the overall quality understanding and support of Lean activities.

Essential qualifications

Bachelor's degree in Chemical Engineer
Minimum 3 years of experience within medical device manufacturing

Preferred qualifications

Microsoft office package, E1, TrackWise, Meridian, Cognos, SharePoint
English (minimum B1 level) reading, writing, and speaking in a conversational level

Required knowledge, skills & abilities

Functional Competences
Quality Systems & Processes
Statistical Analysis & Tools
Technical Writing & Documentation
Regulatory Landscape, Standards & Regulations
System & Data Management
Validation
Design Control
Cross Functional competencies
Business Understanding
Project Management
Self-Management / People Development
Decisionmaking
Collaboration
Communication

Responsible for

Performing their job in compliance with the guidelines given
Drawing attention to the manager to any difficulties in understanding or following the guidelines
Drawing attention to inefficiency of the system

Why Coloplast?

Coloplast develops products and services that make life easier for people with personal and private medical conditions. Working closely with the people who use our products, we create solutions that are sensitive to their special needs. We call this Intimate healthcare.

We are guided by three values

Closeness:
we work closely with our customers to find solutions that meet their specific needs.

Passion:
we work passionately to create new and innovative products that improve the quality of life for our customers.

Respect:
and responsibility we have deep respect for the private nature of the condition our customers face.

Therefore, it's our responsibility to find not only medical solutions, but also ways to minimize the trauma and taboo associated with these conditions.

Our business includes Ostomy Care, Continence Care, Urology Care, and Wound and Skin Care

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

Employing about people and with products available in more than 143 countries, we are one of the world ́s leading medical device companies.

We are constantly growing our business and always looking for new ways to move forward - we explore, learn and look for new ways of doing things.

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