QA Engineer

**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 non-conforming products incl. control of returned goods incl. handling and reporting in TrackWise and handling of lot status in E1
- 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
- Decision-making
- 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 14.000 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.

Watch the film. Follow us on LinkedIn. Like us on Facebook.

54540
LI-CO