Empleos actuales relacionados con Supplier Quality Engineer 2 CR - Alajuela, Alajuela - Hologic

  • Supplier Quality Engineer

    hace 2 semanas

    Alajuela, Alajuela, Costa Rica Confluent Medical Technologies A tiempo completo

    AtConfluent, we are committed to our values of teamwork, innovation, accountability, integrity, leadership, and customer focus, and we invest in a team who represents these values. Every member of our team plays a critical role in delivering life-saving medical devices through innovative materials science, engineering, and manufacturing. We are the medical...

  • Supplier Quality Engineer Staff

    hace 2 semanas

    Alajuela, Alajuela, Costa Rica Confluent Medical Technologies A tiempo completo

    Job Description: At Confluent, we are committed to our values of teamwork, innovation, accountability, integrity, leadership, and customer focus, and we invest in a team who represents these values. Every member of our team plays a critical role in delivering life-saving medical devices through innovative materials science, engineering, and manufacturing. We...

  • Supplier Quality Engineer Staff

    hace 1 semana

    Alajuela, Alajuela, Costa Rica NITINOL DEVICES AND COMPONENTS COSTA RICA SRL A tiempo completo

    Job Description:At Confluent, we are committed to our values of teamwork, innovation, accountability, integrity, leadership, and customer focus, and we invest in a team who represents these values. Every member of our team plays a critical role in delivering life-saving medical devices through innovative materials science, engineering, and manufacturing. We...

  • Sr. Technician, Supplier Quality

    hace 2 semanas

    Alajuela, Alajuela, Costa Rica Terumo Neuro A tiempo completo

    This role supports the supplier quality activities related to development and manufacture of medical devices. The position will work with Engineers to address various product reliability and quality issues. This role will be in charge of the execution of the IQOQ process for RI equipment's, execution of TM, execution of inspection routines, control of...

  • Supplier Quality Intern

    hace 2 semanas

    Alajuela, Alajuela, Costa Rica Medtronic A tiempo completo

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeResponsibilities may include the following and other duties may be assigned.This is a temporary...

  • Manufacturing Engineer 2 CR

    hace 4 días

    Alajuela, Alajuela, Costa Rica Hologic A tiempo completo

    Job SummaryResponsible for supporting and developing medical device manufacturing engineering projects, processes, test and activities for Hologic's product lines. Works with the manufacturing team and supports management goals for manufacturing activity aimed at providing cost efficient operations.Essential Duties and ResponsibilitiesThe incumbent may be...

  • Manufacturing Engineer I

    hace 2 semanas

    Alajuela, Alajuela, Costa Rica Johnson & Johnson MedTech A tiempo completo

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...

  • Manufacturing Engineer I

    hace 2 semanas

    Alajuela, Alajuela, Costa Rica Johnson & Johnson Innovative Medicine A tiempo completo

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...

  • Buyer I, CR

    hace 2 semanas

    Alajuela, Alajuela, Costa Rica Terumo Neuro A tiempo completo

    Perform and/or coordinate the planning, scheduling, procurement, and expediting for specific product lines to meet master schedule and customer order requirements. Also maintain inventory levels. Job duties:Issue purchase orders for direct and indirect materials.Schedule and purchase manufacturing product and assure stock levels.Maintain inventory...

  • Innovation Analyst 2 CR

    hace 4 días

    Alajuela, Alajuela, Costa Rica Hologic Costa Rica A tiempo completo

    Education / Educación:50% completado en Bachillerato en ingeniería Mecánica, Materiales, Electromecánica, Química, Eléctrico, Industrial o carrera a fin.Specialized Knowledge (Desirable) / Conocimiento especializado (Preferible):Deseables cursos de electromecánica, manteamiento preventivo, conocimiento en normas ISO 13485 y normas FDA, mecánica de...

Supplier Quality Engineer 2 CR

hace 3 semanas

Alajuela, Alajuela, Costa Rica Hologic A tiempo completo $60.000 - $80.000 al año

Education / Educación:

  • Advanced English proficiency (spoken and written) is required for effective communication in professional and technical contexts.
  • Bachelor's degree from a university in an Engineering field (Electronic or Mechatronic engineering)

Experience / Experiencia:

  • Minimum 2 years of professional experience, with a Bachelor´s degree, in positions of a similar nature in the medical industry in the technical field, interacting with the quality management system.
  • Full clean driver's license (desirable).

Specialized Knowledge (Desirable) / Conocimiento especializado (preferible):

  • Microsoft Office
  • Project, Visio, Mini Tab
  • Agile: Yes (desirable)

Qualifications / Cualificaciones:

  • Communication—must be able to effectively communicate in both written and verbal forms, and at all levels in the organization.
  • Ability to use problem-solving tools (SPC, TQM, etc.) to optimize processes.
  • Ability to analyze a situation or data; evaluate relevant identifiable factors and translate this information into a meaningful proposal or action plan.
  • High proficiency with Microsoft Office suite to produce reports, analyze data, etc. effectively.
  • Working knowledge of Medical Device Regulations/In Vitro Diagnostic Regulation (as applicable), cGMP, CFR 820, ISO-13485, ISO-14971, ISO-9001.
  • Ability to handle and manage multiple complex projects.
  • Must be able to work independently and with all levels of the organization.
  • ISO 13485 leader auditor (Desirable).
  • Quality System Regulation .
  • Risk management.
  • Validations (IQ, OQ, PQ) and root cause analysis (CAPA process).
  • Knowledge of project management techniques.
  • Measurement system analysis (GR&R, AAA). (Desirable)
  • Statistical Process Controls (SPC) and statistical sampling know how.
  • PPAP (Desirable).
  • Must be able to follow applicable regulations (e.g. FDA, Canada, Brazil, Japan, etc.)

Summary of Duties and Responsibilities / Resumen de funciones y responsabilidades:

Note: The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs.

  • Execute all applicable activities to comply with regulatory standards and meet the requirements established in the Quality Management System around supplier's quality management.
  • Conduct technical reviews of suppliers to understand their capability to make materials.
  • Oversee, assess, and monitor suppliers making parts as it relates to manufacturing, process and quality control practices, corrective action, continuous improvement, and "First Article Inspection".
  • Define and approve PPAP (Production Part Approval Process) requirements for all new and revised purchased parts (as applicable). Follow up for their on-time completion.
  • Work along with suppliers, to exceed the "fit, form and function" and reliability requirements, while working internally with Research & Development and Design Assurance.
  • Issue and follow up on Agile Quality figures called "SCARs" and "SACAs" and "NCEs" related to suppliers. Monitor timing of the workflows to comply with key performance indicators established by Hologic.
  • Work collaboratively with suppliers on problem solving and root cause analysis to avoid repeat failures. Apply (as applicable), metrology and statistical measurement to problem analysis and resolution.
  • Work with Post Market Surveillance and other applicable departments (Quality Engineering, MFG Engineering, Research and Development, R&D, etc.) to address complaints linked to supplier situations.
  • Resolve quality day-to-day issues associated with suppliers around the globe by addressing non-conformities: call into containment and work along with the corresponding departments to achieve disposition of the impacted material (return to supplier, rework, sort, etc.). As applicable, collect and send back samples to suppliers if needed.
  • As a resolve of a PPAP certified part number, work with Incoming Quality to include suppliers in the "Skip Lot Program" (as applicable) or remove suppliers out of it if poor quality is detected.
  • Maintain complete supplier quality records as per the applicable procedure (e.g., supplier performance key indicators, supplier's quality certifications, etc.). Update suppliers' files when required and check that the information is accurate and complete, assuring that all applicable regulatory standards are met
  • Support audits as a subject matter expert. Travel might be required, domestic and international.
  • Update the ERP system with the status of the approved suppliers for the different materials (as applicable).
  • Attend functional and departmental meetings and follow up on action items accordingly.
  • If needed, coordinate/ execute the change in specifications and/or procedures when required through the corresponding change order.
  • Get trained in the respective procedures in the training system, before executing the respective task.
  • Generate supplier performance metrics to be used in decision making. Provide the necessary reports to the stakeholders.
  • As applicable, participate in periodic supplier review meetings, as well as follow up on the activities agreed upon in these meetings to ensure that they are carried out.
  • Coordinate and execute activities related to the implementation of new suppliers as a result of the introduction of new products, transfer of products, alternate suppliers, etc.; ensuring that suppliers comply with the requirements stipulated in the quality system before the closure of the projects.
  • Qualification of new suppliers and/or new parts/components of an already approved supplier.
  • Perform other duties as required by his/her supervisor/manager.