Empleos actuales relacionados con Validation Quality Engineer - Costa Rica - Coloplast

  • Sr. Quality Control Laboratory Engineer

    hace 8 horas

    Costa Rica CooperCompanies A tiempo completo

    The Quality Control Laboratory Engineers will provide support for analytical method validation, including design, protocol, execution, and report. Will also collaborate with senior scientists and leadership on new methods and new equipment implementation and transfer of analytical methods to quality control routine operation through personnel training. Also,...

  • Quality Eng

    hace 2 semanas

    Costa Rica Boston Scientific A tiempo completo

    Additional Locations: N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools,...

  • Quality Engineer

    hace 2 semanas

    Costa Rica Coloplast A tiempo completo

    This is a permanent position to work in our Cartago site, located in Zona Franca La Lima. Medical insurance, asociation, gym, cafeteria subsidy, free transportation and other, are part of our benefits package.Job function summaryQuality Engineer ensures safety, reliability, quality and regulatory compliance to our products, i.e. complying with external and...

  • Senior Product Quality Engineer CR

    hace 2 semanas

    Costa Rica Hologic A tiempo completo

    Education / Educación: University level: A Bachelor of Engineering degree.Experience / Experiencia: Bachelor's degree required in either Mechanical, Biomedical, Biomechanical, or Electrical Engineering with 5+ years' experience, 1-3 years with master's degree, 0-1 Years with PhD.Specialized Knowledge (Desirable) / Conocimiento especializado...

  • Senior Quality Engineer

    hace 2 días

    San José Province, San José, Costa Rica Software Mind A tiempo completo

    Company Description Our client is a leading software company providing financial, tax, and asset management solutions to some of the world's largest energy, utility, and asset-intensive organizations. Their cloud-based platform combines deep domain expertise with modern engineering practices to help clients manage complex regulatory requirements and make...

  • Manufacturing Engineer I

    hace 2 semanas

    Costa Rica TE Connectivity A tiempo completo

    At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.  Job Overview Manufacturing Engineer I is responsible for optimizing, implementing, and standardizing manufacturing processes in manual, semi-automatic, and automatic environments. Analyzes production...

  • Manufacturing Engineer II

    hace 2 semanas

    Costa Rica CooperCompanies A tiempo completo

    The Manufacturing Engineer II is an intermediate engineering position. This position will provide engineering and technical services to internal customers to achieve the overall manufacturing goal of consistently producing quality, low-cost products which meet or exceed customer expectations by addressing major production problems, ensuring optimum...

  • Senior Quality Engineer

    hace 1 semana

    San José Province, San José, Costa Rica Software Mind A tiempo completo

    Company Description We are Software Mind, an awesome team of engineers who are ready to ramp up any top-notch company's projects Our aim? To always be one step ahead. Become part of a multicultural company in constant growth with an excellent work environment certified by Great Place To Work Job Description OverviewSoftware Mind is seeking qualified...

  • Quality Engineer III

    hace 1 semana

    Costa Rica CR Coyol bostonscientific A tiempo completo

    Additional Locations: Costa Rica-CoyolDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that...

  • Technical Services Quality Manager

    hace 6 días

    Costa Rica Terumo BCT A tiempo completo

    Job summary:Leads specified Technical Quality Management Systems team supervising detailed work on a specific portion of a broader task assigned to experienced quality specialists. The Technical Quality Manager will play an integral role in interpreting regulations and standards into Terumo BCT policies and procedures, and owning the ongoing maintenance,...

Validation Quality Engineer

hace 2 semanas

Costa Rica Coloplast A tiempo completo


Job function summary

Leads the IVS project quality and validation activities, providing technical direction, ensuring alignment with quality and regulatory standards, and driving successful project execution across cross‑functional teams, ensures product safety, reliability, and compliance with internal and external quality requirements. The role includes developing and implementing quality control processes, performing risk assessments, and supporting Operations in alignment with the Coloplast Quality Management System. It also involves executing and maintaining processes, equipment, software, and test method validations throughout their lifecycle.

Major areas of accountability

Validation & Test Method Activities

  • Issuing, completing and approving the full validation lifecycle for processes, equipment, software, instruments, and test methods ( Performing Installation Qualification /Operation Qualification).
  • Develop validation strategies and maintain all validation documentation (protocols, reports, deviations, data records).
  • Validate Innovation Value Stream test methods for continuous and attribute data and support design verification testing such as taking out samples and coordinating with production and QA areas.
  • Perform statistical analysis to ensure process and test method robustness and assess any abnormal result and validation troubleshooting by RCA tools.
  • Conduct and update process risk assessments due to new or update of product risks assessment /Design input output, specification, test methods and validation related updates.
  • Perform QA and validation activities for IVS projects, ensuring delivery within scope, schedule, and regulatory expectations.
  • Manage change control tasks related to process validation, software validation, risk assessments, instruction and training and quality action.

Quality Assurance & Risk Management

  • Develop and maintain quality control processes, including control plans, quality plans, Device Master Record content and other quality and regulatory related documentation.
  • Investigate abnormal test results, troubleshoot process issues, and support CAPA and Non-conformance activities (root cause analysis, corrective actions, effectiveness checks).
  • Manage non conformities, returned goods, and product release in the ERP system.
  • Ensure compliance with ISO 13485, MDSAP, MDR, FDA, and corporate QMS requirements

Documentation, Training & Compliance

  • Train stakeholders on QA processes, validation requirements, and regulatory expectations.Manage controlled documents, including product drawings and controlled copies on the production floor.
  • Prepare quality documentation and reports for audits and management reviews.
  • Support EHS culture and comply with internal and external work instructions.

Audits, Continuous Improvement & Collaboration

  • Participate in internal and external audits and ensure readiness of validation and QA documentation.
  • Collaborate with cross functional teams and participate in regular stakeholder meetings.
  • 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.

Responsible for: 

  • 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
  • Support EHS positive culture
  • Ensuring successful completion of project within scope and schedule
  • Performing with focus in the Corporate and department KPIs

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 such MDSAP, MDR, FDA, and corporate QMS requirements (e.g., medical device industry).
  • Experience with Microsoft Office package (Word, Excel, PowerPoint, Outlook).
  • Knowledge in statistical techniques and software applications such as JMP, Minitab, etc.
  • Min. 6-10 years of experience in quality, innovation and validation roles.
  • Fluent in both spoken and written English 
  • B2+ English level 

Prefer qualifications

  • Quality Engineer, Validation Engineer, or NPI engineer certifications.
  • Mobile; capacity to travel abroad to receive training and support transfer activities 
  • C1 English level

Required knowledge, skills & abilities

  • Proven expertise in MS Office and experience with quality systems (e.g., CAPA, NC, Change Control, Document Control, Validation documentation lifecycle)
  • Excellent written and verbal communication skills including influencing and relationship management skills
  • Strong problem-solving and critical thinking skills
  • Excellent knowledge of medical or pharmaceutical regulations.
  • Strict attention to detail
  • Ability to interact professionally with all organizational levels across sites
  • Ability to manage competing priorities in a fast-paced environment

Con unos ambiciosos planes de crecimiento, Coloplast desarrolla y comercializa productos y servicios que hacen la vida más fácil a aquellas personas con necesidades de cuidados sanitarios especiales. Tenemos más de empleados y nuestros productos están disponibles en más de 143 países. Somos una de las empresas líderes de dispositivos médicos a nivel mundial. Constantemente buscamos nuevas formas de hacer crecer el negocio : exploramos, aprendemos y buscamos nuevas formas de hacer las cosas.

Coloplast se compromete a ser una organización inclusiva, donde las diferencias son bienvenidas, las personas desarrollan su potencial y tienen un fuerte sentido de pertenencia debido a  _ no a pesar de_ sus diferencias. Por ello animamos a todos los candidatos idóneos y cualificados a presentar su candidatura independientemente de su sexo, edad, raza, nacionalidad, etnia, orientación sexual, creencia religiosa o capacidad física.

Visítanos en

Ver el vídeo. Síguenos en LinkedIn. Síguenos a Facebook.

60378

#LI-CO