**Location**:
Cartago, Costa Rica, CR
**Job Family**: Quality Assurance
**Country/Region**: Costa Rica
We are looking for an experienced Validation Engineer responsible for the execution of process validation activities under the organizations as well as maintaining the validation life cycle of the machines, process and test method, ensure compliance within external and internal requirements and ensure compliance to the quality management system.
You will report to Validation & Calibration Leader, Coloplast Costa Rica Volume Manufacturing site, Cartago.
Key areas of responsibility
Issuing, completing, and approving validation documentation (protocols, deviations, and reports)
Performing Installation, Operational, and Performance Qualification of equipment, instruments, and machines.
Performing validation of test methods for continues data and attributes.
Performing assessment about software changes and perform validation of software as appropriate
Creation of Software validation plans and validation strategic plans as required
Issuing, updating, and approving Process Risk assessments
Investigating abnormal test results (close collaboration with Quality Engineer and Production Support Engineers and stakeholders).
Troubleshooting validation issues (close collaboration with Quality Engineer and Production Support Engineers and stakeholders).
Handling of Process Validation and Risk assessments related Change Request tasks.
Collecting, organizing, and documenting test data.
Statistical analysis of data for process and test methods validation.
Ensuring accurate records of all validation activities.
Performing activities in a timely manner.
Performing with focus in the Corporate and department KPIs
Participation in internal and external audits as required.
Maintaining validation documentation throughout the validation life cycle.
Comply with internal and external instructions and work discipline in connection with work.
Participation on cross-functional teams.
Perform other duties within quality processes, as necessary.
**Your qualifications**:
Bach.
degree in an Engineering field, such industrial, electrical, mechanical, etc.
Understanding and Knowledge of the quality system standards ISO 13485 and ISO 9001.
Experience in regulated industries (e.g., medical device industry).
Experience with Microsoft Office package (Word, Excel, PowerPoint, Outlook).
Experience with statistical software such as JMP, Minitab, etc.
Min.
3 years of experience in quality or production roles.
Fluent in both spoken and written English
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 and negotiation abilities, experience in a start-up process and a high degree of flexibility.
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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