Validation Engineer

hace 3 días


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 Engineer will be responsible for the execution of process and software 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.
Major areas of accountability
- Issuing, completing, or approving validation documentation (protocols, deviations, reports, etc.)
- 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, Software 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 related to projects for new machines, transfer machines, item extensions or any other project where validation assessment or 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
- 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

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

Essential 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

Preferred qualifications
- Numerical skills and understanding of data analysis/statistical methods.
- Experience performing in validation roles
- Mobile; capacity to travel abroad to received training and support transfer activities

Required knowledge, skills & abilities

Functional competencies*
- Quality Systems & Processes
- Statistical Analysis & Tools
- Technical Writing & Documentation
- Regulatory Landscape
- Standards & Regulations
- System & Data Management
- Validation
- Design Control

Cross-functional competencies
- Project Management
- Self-Management
- Decision-making
- Collaboration
- Communication

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


  • Validation Engineer

    hace 3 días


    Provincia de Cartago, Costa Rica Coloplast A tiempo completo

    **Ubicación**: Cartago, Costa Rica, CR **Familia de puestos**: Control de Calidad **País**: Costa Rica Job function summary The Validation Engineer will be responsible for the execution of process and software validation activities under the organizations as well as maintaining the validation life cycle of the machines, process, and test method, ensure...

  • Validation Engineer

    hace 2 semanas


    Cartago, Costa Rica Tekni-Plex A tiempo completo

    **SUMMARY**: The Validation Engineer will be responsible for performing and overseeing the validation of manufacturing processes. Support the quality assurance of all activities within the process, ensuring that all systems are running according to the specifications and operations standards monitoring budget, and controlling purchase and...


  • Cartago, Costa Rica Coloplast A tiempo completo

    **Location**:Cartago, Costa Rica, CR**Job Family**: Quality Assurance**Country/Region**: Costa RicaSoftware Validation Engineer, Coloplast CartagoAre 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...

  • Validation Engineer

    hace 5 días


    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 Engineer will be responsible for the execution of process and software validation activities under the organizations as well as maintaining the validation life cycle of the machines, process, and test method, ensure...

  • Test Method

    hace 6 días


    Cartago, Costa Rica Coloplast A tiempo completo

    **Location**:Cartago, Costa Rica, CR**Job Family**: Quality Assurance**Country/Region**: Costa RicaJob function summaryThe Test Method and Process Validation Engineer will be responsible for the execution of process validation, with specialization in test method validation, and test equipment within the organization.Maintaining the validation life cycle of...

  • Validation Technician

    hace 7 días


    Cartago, Costa Rica Coloplast A tiempo completo

    **Location**:Cartago, Costa Rica, CR**Job Family**: Quality Assurance**Country/Region**: Costa RicaValidation TechnicianDo 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...

  • Validation Technician

    hace 5 días


    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...

  • Engineer Ii, Quality

    hace 7 días


    Cartago, Costa Rica Boston Scientific Corporation A tiempo completo

    **Engineer II, Quality**:- Remote Eligible: Onsite- Onsite Location(s): Cartago, CR**Additional Locations**: N/A**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High Performance**At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing...

  • Sr Engineer Quality

    hace 4 días


    Provincia de Cartago, Costa Rica Edwards Lifesciences A tiempo completo

    **Key Responsibilities**: - Write, review and/or approve validation protocols and reports (e.g., cleanroom, equipment, test method and product transfer validation protocols) in accordance with applicable Regulations, Edwards Lifesciences SOPs and Good Documentation Practices (GDP) Utilize test equipment to verify equipment parameters, process outputs or...


  • Provincia de Cartago, Costa Rica Boston Scientific Corporation A tiempo completo

    **Engineer II, Quality temporary position 12 months**: - Remote Eligible: Onsite- Onsite Location(s): Cartago, CR**Additional Locations**: N/A **Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of...

  • Engineer Ii

    hace 2 días


    Provincia de Cartago, Costa Rica Heraeus Holding GmbH A tiempo completo

    **Process Development Engineer II** **Summary** Hands-on engineer responsible for providing expertise in developing manufacturing processes for electrophysiology catheters, and similar products. Demonstrates competence in medical device and manufacturing environment. Support and own processes from development through production including process...


  • Cartago, Costa Rica Nextern A tiempo completo

    **SUMMARY** A process development engineer plans, designs and executes cost-effective production systems, in order to enhance the speed and quality of processing, and ensure produced items comply with international regulations and industry standards. Process development engineers use technical knowledge and industry expertise to review existing...


  • Cartago, Costa Rica Boston Scientific A tiempo completo

    Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance   At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health.That is why we stand for inclusion, equality, and opportunity...

  • R&D Engineer

    hace 7 días


    Cartago, Costa Rica Nextern A tiempo completo

    This position will be responsible for coordinating and executing new product development according to customer specifications, developing hands-on product solutions and supporting the business development cycle for Nextern.The R&D Engineer aids in managing a complete device project from the early concept, through Nextern's detailed phase gate development,...


  • Cartago, Costa Rica Boston Scientific Corporation A tiempo completo

    **Work mode**:Hybrid**Onsite Location(s)**:Cartago, CR**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance**- At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health.That is...

  • Quality Engineer

    hace 6 días


    Cartago, Costa Rica Coloplast A tiempo completo

    **Location**:Cartago, Costa Rica, CR**Job Family**: Quality Assurance**Country/Region**: Costa RicaAre 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 committed, collaborative and experienced Quality Engineer to take up a position in our growing...


  • Cartago, Costa Rica Boston Scientific Corporation A tiempo completo

    **Engineer II, Quality Sys**:- Remote Eligible: Onsite- Onsite Location(s): Cartago, CR**Additional Locations**: N/A**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High Performance**At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing...

  • Production Engineer

    hace 4 días


    Cartago, Costa Rica Rau Precision Metals S.A. A tiempo completo

    ACERCA DE LA VACANTEFunciones del Puesto- Planning and controlling work on the shop floor.- Determine and assure quality standards.- Preparation and controlling machines and tools.- Supervising work in the shop.- Training and instruction of workers.- Control and follow-up used production times of closed working steps and orders.- Manage of human and material...


  • Cartago, Costa Rica Boston Scientific Corporation A tiempo completo

    **Work mode**:Onsite**Onsite Location(s)**:Cartago, CR**Additional Locations**: N/A**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance**- At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and...

  • Quality Engineer

    hace 7 días


    Cartago, Costa Rica Coloplast A tiempo completo

    **Location**:Cartago, Costa Rica, CR**Job Family**: Quality Assurance**Country/Region**: Costa RicaOur Quality Engineer ensures compliance to external and internal quality requirements and provides support to Operations value stream in accordance with Coloplast Quality Management System.Major areas of accountabilityCreate and maintain quality related...