Software Validation Engineer

hace 19 horas

Provincia de Cartago, Costa Rica Coloplast A tiempo completo

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

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

Software Validation 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 Software Validation Engineer to ensure the execution of software validation activities under the organizations as well as maintaining the validation life cycle of the machines, process, and test equipment, ensure compliance within external and internal requirements and ensure compliance to the quality management system. You will be 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

Issuing, completing, or approving validation documentation (protocols, deviations, reports, etc.)
Performing Software Release Testing, Installation, Operational and Performance qualification of production equipment, and production machines in alignment with the corporate instructions.
Performing assessment about software changes and perform validation of software as appropriate
Creation of software validation plans
Issuing, updating, and approving Process Risk assessments
Investigating abnormal test results (close collaboration with Quality Engineer, Production Support Engineers, engineering departments, project leaders and other stakeholders).
Troubleshooting validation issues (close collaboration with Quality Engineer, Production Support Engineers, engineering departments, project leaders and other stakeholders).
Handling of Software validation and Risk assessments related Change Request tasks.
Collecting, organizing, and documenting test data.
Ensuring accurate records of all validation activities.
Support in the revision and approval of supplier documentation such as FAT and SAT etc according to Coloplast procedures.
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 related to projects for new machines, transfer machines, item extensions, critical and non-critical machine software changes, or any other project where software validation assessment or software validation activity is needed.
Executes tasks to the ordinance of the superior or upon his initiative, which are not listed in the job description, but based on the job it is part of his job, or in case of emergency or if it is additional part of his job

**Your qualifications**:
Bach. degree in an Engineering field such as in Information technologies, systems, electrical, electronic or electromechanics fields.
Understanding and Knowledge of the quality system standards ISO 13485 and ISO 9001.
Knowledge in GAMP5 guidelines, FDA 21 CFR Part 820 and 11 desired
Experience in regulated industries (e.g., medical device industry).
Experience with Microsoft Office package (Word, Excel, PowerPoint, Outlook).
Min. 3 years of experience in quality, engineering, 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 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

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