Quality Systems Engineer

**Location**:
Cartago, Costa Rica, CR

**Job Family**: Quality Assurance
**Country/Region**: Costa Rica

Quality Systems Engineer

Quality System Engineer, Coloplast Cartago

Are you motivated by quality control of medical device products with the purpose of improving the lives of people with intimate health care needs?

We are looking for a dedicated Quality System Engineer to ensure compliance of quality management system with external and internal requirements before our medical device products reaches our users. You will be a part of a growing quality team, as Coloplast is in the process of establishing a world-class manufacturing site in Cartago, Costa Rica.

You will report to Head of Quality, Coloplast Costa Rica Volume Manufacturing site, Cartago.

Key areas of responsibility

Monitoring, maintaining, and improving the Quality systems (Veeva, TrackWise, STEP, E1)

Supervising, monitoring the Change Control database and verifying the changes

Reporting of local QA KPIs and reporting from Quality systems (Veeva, TW, STEP, E1)

As local process owner represents the site and make the training about the changes of the procedures

Maintain and improve the document handling / archiving processes

Support and active member during internal and external audits

Ensure compliance with Coloplast Quality Management system

Recommend and implement quality improvements of products/processes

Contact with local departments and headquarter in Denmark

Organize and make yearly Quality trainings

**Your qualifications**:
BSc in Engineering or Certified Quality Engineer

Familiar with quality system standards ISO 13485, ISO 9001, MDSAP, MDD / MDR, 21CFR 820

Min. 2 years related experience in medical device industry with thorough knowledge of methodologies of quality assurance and standards

Excellent numerical skills and understanding of data analysis

Good knowledge of MS Office and databases

English B3 level

As a person, you are ambitious and a collaborative team player with a positive can-do attitude. You have attention to details, as well as demonstrate problem-solving -, analytical -, and critical thinking skills. It is a benefit, if you have proven ability to collaborate with cross functional teams in different geographies, and experience in a start-up process.

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 12.000 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.

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