Quality Engineer 3

hace 2 días

Heredia, Costa Rica Viant Medical A tiempo completo

**Main Purpose of Job**:
Provide Quality Engineering support to the development and production of Class I, II and III (as applicable) Medical Devices. Represent Quality in production process efforts, quality planning, process validations, FMEA and Risk Analysis, support new product development activities, maintain and manage quality compliance and supplier quality management. Support finished goods variance investigation and resolution, complaint investigation, process improvement and quality assurance testing methodology. Participate in or lead Corrective/Preventive Action initiatives. Support internal/ external and suppliers audit, vendor qualification and training programs. Participate in Quality/ Business initiatives including business process improvement activities, documented Quality System re-architecture and other cross-functional projects.
Knowledge / Education
- Minimum education required to perform duties: Bachelor degree in Engineering or Science (such as Pharmacy, Microbiology, Physics and Chemistry).
- Bilingual English/Spanish - Advanced English level (written and spoken).
- Knowledge of applicable regulations for the medical device industry (FDA, ISO, other.)
- Knowledge of test method validation.
- Knowledge in root cause analysis tools.
- Knowledge of Minitab statistical software.
- Knowledge of Six Sigma Methodology and Lean Manufacturing.

Job Experience
- At least 2 years work experience in manufacturing environment.
- Project Management experience.
- At least one year in current position.
- No disciplinary actions of less than three months.

**Responsibilities**:

- Coordinate the development of new processes inspections by interfacing with personnel from product design and development, quality assurance, production, manufacturing, process/assembly technology and external vendors / customers.
- Participate in the preparation of quality metrics required for Management Review, Operations Review or Quality Metrics meetings.
- Review drawings, analyze tooling, and recommend improvements leading to increase productivity, quality, and safety for new or existing manufacturing processes.
- Coordinate and carry out qualification and validation activities for new products, processes, changes and transfers as per FDA regulations (IQ, TMV, OQ, PQ and Quality Plans). Prepare respective validation protocols and reports for moderate and high complexity qualifications or participate in the approval of them.
- Executes investigations for audit non-conformances, complaints and Corrective and Preventive Actions (CAPA) to correct a problem presented in the quality system or the manufacturing process.
- Responsible for the elaboration of risk management documentation such as Risk Management Plan / Report and Process FMEAs.
- Become supervisor of Quality Inspectors / Technicians / Specialists and be responsible for the tasks assignation / coordination of this personnel in charge.
- Train Quality Assurance Inspectors and manufacturing personnel in understanding of procedures, specifications, environmental controls, etc.
- Act as a quality system internal auditor. Participate in communications with the customers including weekly sustaining report out meetings, QBRs, projects meetings, other.

Viant proporciona igualdad de oportunidades de empleo (EEO) a todos los empleados y solicitantes de empleo sin tener en cuenta la raza, color, religión, género, orientación sexual, nacionalidad, edad, discapacidad, estado civil, amnistía, o estatus como veterano cubierto de acuerdo con las leyes federales, estatales y locales aplicables. Viant cumple con las leyes estatales y locales aplicables que rigen la no discriminación en el empleo en todos los lugares en los que la empresa tiene instalaciones.

  • Quality Engineer 3

    hace 1 día

    Heredia, Costa Rica Viant Medical A tiempo completo

    **Main Purpose of Job**: Provide Quality Engineering support to the development and production of Class I, II and III (as applicable) Medical Devices. Represent Quality in production process efforts, quality planning, process validations, FMEA and Risk Analysis, support new product development activities, maintain and manage quality compliance and supplier...

  • Quality Engineer Assistant

    hace 3 días

    Heredia, Costa Rica Viant Medical A tiempo completo

    Responsibilities - Under the direction of Quality / New Product Introduction (NPI) or other technical managerial position and depending on the incumbent´s level of knowledge and Education, he/she will assist the engineers in projects related activities such as: documents preparation, documents translations, component specification, item master creations,...

  • Quality Engineer Assistant

    hace 3 días

    Heredia, Costa Rica Viant Medical A tiempo completo

    Responsibilities - Under the direction of Quality / New Product Introduction (NPI) or other technical managerial position and depending on the incumbent´s level of knowledge and Education, he/she will assist the engineers in projects related activities such as: documents preparation, documents translations, component specification, item master creations,...

  • Quality Engineer Iii

    hace 7 días

    Heredia, Costa Rica Viant Medical A tiempo completo

    **Job Title**: Quality Engineer (Process, Systems and Supplier)**Department**: Quality Assurance**Document Purpose**: this document serves as guidance to establish the professional classification in the quality engineering area, defining specific and general activities that require revision on each position to establish the correct scope and...

  • Quality Engineer

    hace 1 semana

    Heredia, Costa Rica HUBER+SUHNER A tiempo completo

    At HUBER+SUHNER, we design and create essential components that transport power and data through networks. This is how our employees around the globe contribute to a world where people get and stay connected. **Quality Engineer**: **Heredia** | **Full-time** | **Unlimited*** **Your tasks**: - Directly responsible for ensuring all quality standards for...

  • Molding Engineer 3

    hace 4 días

    Heredia, Costa Rica Viant Medical A tiempo completo

    **Job Title**: Molding Engineer 3 **Department**: Engineering - Molding and/or Extrusion Knowledge / Education - Minimum education required to perform duties: Bachelor degree in Engineering (i.e. Mechanical, Manufacturing, Industrial Engineering or science related engineering discipline, etc.) - Proficient in Microsoft Office. - Bilingual English/Spanish -...

  • Molding Engineer 3

    hace 4 días

    Heredia, Costa Rica Viant Medical A tiempo completo

    **Job Title**: Molding Engineer 3 **Department**: Engineering - Molding and/or Extrusion Knowledge / Education - Minimum education required to perform duties: Bachelor degree in Engineering (i.e. Mechanical, Manufacturing, Industrial Engineering or science related engineering discipline, etc.) - Proficient in Microsoft Office. - Bilingual English/Spanish -...

  • Quality Assurance Engineer

    hace 3 días

    Heredia, Costa Rica SGF Global A tiempo completo

    **Quality Assurance Engineer (Remote)** **Heredia, Costa Rica** SGF Global is looking for a Quality Assurance Engineer, for IT enterprise in Heredia, Costa Rica. **Overview**: **Requirements**: - Bachelor's Degree in Computer Science or related field - 3 years of technical testing experience - Isolates, reproduces, and tracks defects and verifies fixes -...

  • Quality Engineer

    hace 4 días

    Heredia, Costa Rica GRUPO PRESELECCION ELY S.A. A tiempo completo

    **Requisitos**: What You Will Need Bachelor’s Degree in Electrical, Electronic, Industrial Engineering or related Engineering discipline Advanced English level (MUST) Experience of 6 to 8 years as Quality Engineer. Experience using data mining software such as JMP and SPOTFIRE Exposure to Six Sigma and Lean Principals Problem Solving, 8D and FMEA...

  • Quality Engineer

    hace 7 días

    Heredia, Costa Rica Huber+Suhner A tiempo completo

    At HUBER+SUHNER, we design and create essential components that transport power and data through networks.This is how our employees around the globe contribute to a world where people get and stay connected.**Quality Engineer**:**Heredia** | **Full-time** | **Unlimited*****Your tasks**:- Directly responsible for ensuring all quality standards for products...

  • Engineer Ii, Quality

    hace 2 semanas

    Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Engineer II, Quality**: - Remote Eligible: Onsite- Onsite Location(s): Heredia, H, 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 diverse and high-performing...

  • Engineer Ii, Quality

    hace 7 días

    Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Engineer II, Quality**:- Remote Eligible: Hybrid- Onsite Location(s): Heredia, H, CR**Additional Locations**: Costa Rica-Heredia**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 diverse and high-performing...

  • Engineer I, Quality

    hace 7 días

    Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Engineer I, Quality**:- Remote Eligible: Hybrid- Onsite Location(s): Heredia, H, 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...

  • Engineer Ii, Quality

    hace 1 día

    Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Engineer II, Quality**: - Remote Eligible: Hybrid- Onsite Location(s): Heredia, CR**Additional Locations**: Costa Rica-Heredia **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...

  • Quality Engineer Ii

    hace 7 días

    Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Work mode**:Hybrid**Onsite Location(s)**:Heredia, H, 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 diverse and high-performing employees, tackling some of the most...

  • Data Quality Engineer

    hace 7 días

    Heredia, Costa Rica Moody'S A tiempo completo

    Moody's is a global integrated risk assessment firm that empowers organizations to make better decisions.**Overview**:At Moody's Analytics, we are more than just a team - we are a dynamic group of information architects, innovative thinkers, and passionate problem solvers.We invite you to be a part of our mission to ensure the utmost reliability and accuracy...

  • Quality Engineer

    hace 7 días

    Heredia, Costa Rica Viant Costa Rica A tiempo completo

    ACERCA DE LA VACANTEFunciones del PuestoProvide Quality Engineering support to the development and production of Class I, II and III (as applicable) Medical Devices.Represent Quality in production process efforts, quality planning, process validations, FMEA and Risk Analysis, support new product development activities, maintain and manage quality compliance...

  • Senior Quality Engineer

    hace 6 días

    Heredia, Costa Rica Sgf Global A tiempo completo

    **Senior Quality Engineer (Hybrid)****Heredia, Costa Rica**SGF Global is looking for a Senior Quality Engineer, for IT enterprise in Heredia, Costa Rica.**Requirements**:- Bachelor's degree in computer science or equivalent required.- Strong expertise in identifying the scope of automation, driving the automation test development.- Programming Languages: -...

  • Engineer, Prin Quality Job

    hace 7 días

    Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Engineer, Prin Quality Job**:- Remote Eligible: Hybrid- Onsite Location(s): Heredia, H, 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...

  • Engineer I, Quality Job

    hace 7 días

    Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Engineer I, Quality Job**:- Remote Eligible: Onsite- Onsite Location(s): Heredia, CR**Additional Locations**: Costa Rica-Heredia**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...