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Validation Technician

hace 1 mes

Provincia de Cartago, Costa Rica Coloplast A tiempo completo

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

**Job Family**: Quality Assurance

**Country/Region**: Costa Rica

Job function summary

The Validation Technician will work on the production floor to ensure compliance within process validation with external and internal requirements and ensure compliance to the quality management system.

Major areas of accountability
- Issuing and completing validation documentation (protocols, deviations, reports).
- Performing and qualifying Installation, Operational, and Performance Qualification of equipment, instruments, and machines.
- Investigating abnormal test results (close collaboration with Quality Engineer, Validation Engineer and Production Support Engineers).
- Troubleshooting validation issues (close collaboration with Quality Engineer, Validation Engineer and Production Support Engineers).
- Collecting, organizing, and documenting test data.
- Statistical analysis of validation data.
- Ensuring accurate records of all validation activities.
- Performing activities in a timely manner.
- Participation in internal and external audits as required.
- Maintaining validation documentation throughout the validation life cycle.
- Comply with internal instructions and work discipline in connection with work.
- Participation on cross-functional teams.
- Perform other duties within quality processes, as necessary.

Additional Areas of Accountability
- 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
- 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
- Take responsibility for those safety aspects identified for the given position

Essential qualifications
- Technical degree in Productivity or Quality.
- English B1+
- Familiar with quality system standards ISO 13485 and ISO 9001.

Preferred qualifications
- Computer knowledge and good typing skills required: MS Office (Word, Excel), Outlook and databases.
- Numerical skills and understanding of data analysis/statistical methods.

Required knowledge, skills & abilities
- Self-motivated and a genuine interest in improving processes and internal customer relationships.
- Good documentation and time management skills.
- Must work well independently or in a team and be adaptable/flexible.
- Attention to detail and the ability to follow work instructions.
- An understanding of the importance of customer focus.
- Ability to meet deadlines.
- Ability to effectively interact with various internal and external customers/vendors.
- Ability to maintain a good working relationship with coworkers and staff.
- Ability to organize efficiently and effectively, good structure.
- Ability to convey a positive and professional image to internal and external customers.
- Ability to exercise logical and sound judgment.
- Proficient problems solving skills.

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

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.

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