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- Drafting, completing, and approving validation documentation including protocols, deviations, and reports.
- Conducting Installation, Operational, and Performance Qualification of equipment and instruments.
- Validating testing methods for continuous data and attributes.
- Assessing software modifications and validating software as necessary.
- Developing software validation plans and strategic validation approaches as required.
- Issuing, revising, and approving Process Risk Assessments.
- Investigating unexpected test outcomes in collaboration with Quality Engineers and Production Support Engineers.
- Resolving validation challenges in close cooperation with Quality Engineers and Production Support Engineers.
- Managing Process Validation, Software Validation, and Risk Assessment tasks related to Change Requests.
- Collecting, organizing, and documenting testing data effectively.
- Performing statistical analysis of data for the validation of processes and testing methods.
- Maintaining accurate records of all validation activities.
- Executing tasks promptly and efficiently.
- Focusing on Corporate and departmental Key Performance Indicators (KPIs).
- Participating in internal and external audits as required.
- Keeping validation documentation updated throughout the validation lifecycle.
- Adhering to internal and external guidelines and maintaining work discipline.
- Collaborating on cross-functional teams for projects involving new machinery, machine transfers, or any project requiring validation assessment.
- Carrying out additional tasks as directed by supervisors, including those not explicitly listed in the job description, especially in emergencies or as part of job responsibilities.
- Bachelor’s degree in an Engineering discipline such as industrial, electrical, or mechanical engineering.
- Knowledge of quality system standards, specifically ISO 13485 and ISO 9001.
- Experience in regulated sectors, particularly in the medical device industry.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
- Familiarity with statistical software tools like JMP or Minitab.
- Minimum of 3 years of experience in quality assurance or production roles.
- Proficient in both spoken and written English.
- Strong numerical skills and understanding of data analysis/statistical methods.
- Previous experience in validation roles.
- Willingness to travel internationally for training and support activities.
Software and Process Validation Analyst - Cartago, Costa Rica - Coloplast
Descripción
Job Function Overview
The Quality Assurance Validation Specialist will oversee the implementation of process and software validation tasks within the organization. This role is essential for maintaining the validation lifecycle of machinery, processes, and testing methodologies, ensuring adherence to both internal and external standards while upholding the quality management system.
Key Responsibilities
Essential Qualifications
Preferred Qualifications
Coloplast is committed to fostering an inclusive organization where differences are embraced, and individuals can develop their potential while feeling a strong sense of belonging. We encourage all qualified candidates to apply, regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious beliefs, or physical ability.
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