Quality Engineer Ii

hace 6 meses

Heredia, Costa Rica Viant Medical A tiempo completo

Provide Quality Engineering support to the development and production of Class II 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.
Main Job Duties/Responsibilities
- Prepare and update quality documents and any applicable documentation required to sustain the manufacturing process, system or NPI projects, including but not limited to documentation linked to the Device Master Records and Device History Records.
- Execute reviewing / approval of any documentation created / updated by the Manufacturing Engineering department (or other) required to sustain the manufacturing process or quality systems.
- Support in analysis, review and implementation of new methodologies, processes, tools that contribute to the improvement on the manufacturing process, quality systems or supplier improvements.
- Checks, provides support and executes initiation / investigation for NCs, Complaints, Calibration, SCARs and Environmental Monitoring.
- Provide follow up to actions generated from corrective and preventive plans.
- Performs other duties, tasks, or projects at the direction of the immediate supervisor or other teammates.
- Support in the execution of qualifications (IQs/OQs/PQs/PPQs/TMVs) with an approved protocol; gather data and analysis results for completing the corresponding report.
- Assure that all laboratory equipment is in compliance to perform the analysis and testing activities (quality labs, calibration, microbiology and incoming).
- Participates in all the readiness activities required to receive Internal / External / Customer / Suppliers Quality System Audits.
- Collaborate in the elaboration of risk management documentation such as Risk Management Plan / Report and Process FMEAs.
- Review protocols and reports for IQ, OQ, PQ, PPQ and TMV; as well as any other document related to validation.
- Prepare respective validation protocols and reports for low and moderate complexity qualifications or participate in the approval of them. Participates on the definition of validation strategies.
- Elaboration of Validation Master Plans to define / document all the validation strategy required to implement a new product / process or change a current one. Also, elaborate the Validation Master Plan Closure once all the activities have been executed
- Read and interpret technical drawings provided by the customer and elaborates the related documentation such as of QA Specs, Control Plans, other.
- Elaboration of work instructions, automated routines or any other document required to execute inspections. Also, validate these inspections through TMV Protocols and TMV Reports.
- Participate in the communications with the customers including projects, product/process transfers, weekly sustaining report out meetings, Quarterly Business Reviews, other.

Knowledge / Education
- Minimum education required to perform duties: Bachelor's degree in engineering or science (such as Pharmacy, Microbiology, Physics and Chemistry).
- Bilingual English/Spanish - Intermediate English level, reading and listening comprehension, writing and oral expression.
- Basic knowledge of applicable regulations for the medical device industry (FDA, ISO, other.)
- Basic knowledge in root cause analysis tools.
- Basic knowledge of process validation.
- Knowledge of Six Sigma Methodology and Lean Manufacturing is a plus.
- Knowledge of Minitab statistical software is a plus.

Job Experience
- At least 1-year work experience in manufacturing environment.
- Project Management experience is a plus.
- Experience within the medical device manufacturing or pharmaceutical fields, or any other highly regulated industry (i.e. food, aerospace, etc.) is a plus.

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 Ii

    hace 6 meses

    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...

  • Quality Engineer Iii

    hace 7 meses

    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 - Quality Engineer Ii - Sustaining

    hace 6 meses

    Heredia, Costa Rica Viant Medical A tiempo completo

    Provide Quality Engineering support to the development and production of Class II 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...

  • Engineer Ii, Systems Heredia

    hace 6 meses

    Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Engineer II, Systems HEREDIA**: - Work mode: 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 recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is...

  • QA Automation Engineer Ii, Costa Rica

    hace 7 meses

    Heredia, Costa Rica West Monroe Experienced A tiempo completo

    **Are you ready to make an impact?** **West Monroe** is seeking a QA Automation Engineer II for our Product Experience & Engineering Lab (PXEL) Practice. QA Automation Engineers work in a variety of industries including growth startups, finance, healthcare, insurance, energy and many more. You will work directly with a product team to understand their...

  • Quality Engineer Assistant

    hace 6 meses

    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 6 meses

    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 Ii Heredia Turno B

    hace 6 meses

    Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Work mode**:Onsite**Onsite Location(s)**:Heredia, H, CR**Additional Locations**: Costa Rica-Heredia**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...

  • Quality Engineer Ii, Heredia Turno C

    hace 6 meses

    Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Work mode**:Onsite**Onsite Location(s)**:Heredia, H, CR**Additional Locations**: Costa Rica-Heredia**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...

  • Quality Engineer Junior Temporary

    hace 6 meses

    Heredia, Costa Rica Viant Medical A tiempo completo

    **Job Title**: Quality Engineer Junior Temporary **Department**: Quality Assurance - ____________________________________________ **Main Purpose of Job**: (Brief Summary) - Provide Quality Engineering support to the development and production of Class I and II Medical Devices. Represent Quality in production process efforts, quality planning, FMEA and Risk...

  • Quality Engineer

    hace 6 meses

    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...

  • Quality Engineer 3

    hace 6 meses

    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 3

    hace 6 meses

    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...

  • Senior Quality Engineer

    hace 7 meses

    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...

  • Engineer Ii, Test

    hace 6 meses

    Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Work mode**:Onsite**Onsite Location(s)**:Heredia, H, 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....

  • Sr Supplier Quality Engineer

    hace 7 meses

    Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Work mode**:Hybrid**Onsite Location(s)**:Heredia, CR**Additional Locations**: Costa Rica-Heredia**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...

  • Quality Engineer

    hace 6 meses

    Heredia, Costa Rica NTT DATA A tiempo completo

    **Req ID**: 280099 We are currently seeking a Quality Engineer to join our team in Heredia, Heredia (CR-H), Costa Rica (CR). **Position overview**: **Position's General Duties and Tasks**: - Experience in automated execution using Automation tools. - Progress reporting and risk assessments - Proficient in different phases of testing like Functional, E2E,...

  • Data Quality Engineer

    hace 6 meses

    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...

  • Web Quality Assurance Engineer

    hace 6 meses

    Heredia, Costa Rica 360training A tiempo completo

    **(QA Engineer)** **Web Quality Assurance Engineer** **Responsibilities** - Review requirements, specifications, and technical design documents to provide timely and meaningful feedback. - Collaborate with cross-functional teams to ensure seamless integration and functionality of the web platforms. - Create detailed, comprehensive, and well-structured test...

  • Manufacturing Engineer Assistant

    hace 6 meses

    Heredia, Costa Rica Viant Medical A tiempo completo

    **Job Title**: Manufacturing Engineer Assistant **Main Purpose of Job**: (Brief Summary) - The individual in this position shall work with Manufacturing, Quality, Production, Administrative and Technical personnel of the campus to gather and provide information required by Engineering as required to ensure the achievement of expected quality levels,...