**Location**:
Cartago, Costa Rica, CR
**Job Family**: Quality Assurance
**Country/Region**: Costa Rica
Validation Technician
Do you have a quality mindset working within the medical device industry and have proven record of conducting process validation of machines?
Then you are the one we are searching for to join our Quality Assurance team at Coloplast Cartago.
You will report to Head of Quality, Coloplast Costa Rica Volume Manufacturing site, Cartago.
Key areas of responsibility
Completing validation documentation (protocols, deviations, and reports) and perform Installation, Operational, and Performance Qualification of machines.
Investigating and troubleshooting validation issues (close collaboration with Quality Engineer, Validation Engineer and Production Support Engineers).
Ensuring accurate records of all validation activities and in a timely manner.
Participation in internal - and external audits as required.
Maintaining validation documentation throughout the validation life cycle.
**Your qualifications**:
Technician in Quality or Production
Familiar with quality system standards ISO 13485 and ISO 9001.
Min.
3 years related experience in medical device industry with thorough knowledge of methodologies of quality assurance and standards
Good numerical skills and understanding of data analysis/statistical methods
Good knowledge of MS Office and databases
English B2 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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