Principal Engineer Quality

hace 2 semanas

Provincia de Cartago, Costa Rica Edwards Lifesciences A tiempo completo

Ensure compliance of the QMS and compliance within quality processes (e.g., CAPA. NCR, ECR, internal and external auditing, training). Maintain quality reporting inclusive quality and production indicators.

**Key Responsibilities**:

- Provide complex assessments including audits to ensure conformance with applicable regulations and EW policies and procedures. Assess objective evidence to determine conformity to requirements listed above, including ranking the levels of nonconformance findings
- Provide technical guidance and lead projects, based on understanding of international standards and regulations, to business unit and/or corporate quality initiatives including special projects, such as designing and/or recommending systems, procedures, etc.
- Plan annual audit schedule, determine and assign SMEs to audits, establish audit content, allocate time, and schedule meetings. Assess previous audit findings to establish priorities and strategies
- Execute audit considering scope to assure efficient and effective use of scheduled time allocations
- Identify, lead and implement business process improvement solutions for Quality Systems, including developing changes to procedures, to improve operation, efficiencies, and user experience, while supporting the integrity of the business process. Local process owner for quality system processes (e.g., CAPA, NCR, internal auditing, risk management)
- Provide teams first-level support to Quality, Documentation and PCS Systems users, e.g., CAPA, NCR, Change, Training, Maintenance, for system usage and process requirements
- Recommend changes to documentation associated with Quality, Documentation and PCS Systems, including assessing effectiveness and approving recommendations others
- Identify continuous improvement opportunities including performing complex analysis and may present metrics to all level of the organization
- Train, coach, and guide lower level employees on more complex procedures
- Other incidental duties

**Education and Experience**:
Bachelor's degree in engineering or Scientific field, 6 years of experience minimum of experience, including either industry or industry/education Required or
Master's Degree or equivalent in Engineering or Scientific field, 5 years of experience minimum, including either industry or industry/education Required or
Ph.D. or equivalent in in Engineering or Scientific field, 2 years of experience minimum of experience, including either industry or industry/education Required

**Additional Skills**:

- Proven expertise in MS Office Suite and experience with quality systems (e.g., CAPA, Ignite)
- Experienced in GxP
- Good project management skills and related software tools preferred
- Excellent written and verbal communication skills including influencing and relationship management skills
- Strong problem-solving and critical thinking skills
- Ability to read, comprehend, write and speak English fluently, required
- Full knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality systems
- Excellent knowledge of medical or pharmaceutical regulations as relating to documentation
- Excellent understanding of medical devices regulations (e.g., FDA (21 CFR Part 820) and ISO13485, ISO14971, and MDD)
- Strict attention to detail
- Ability to interact professionally with all organizational levels across sites
- Ability to manage competing priorities in a fast paced environment
- Ability to work in a team environment, including inter-departmental teams and key contact representing the organization on projects and for compliance topics
- Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
- Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

About Edwards Lifesciences

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.

For us, helping patients is not a slogan - it’s our life’s work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

COVID Vaccination Requirement

**For United State

  • Quality Engineer

    hace 4 semanas

    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 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 accountability - Create...

  • Quality Engineer Ii

    hace 1 mes

    Provincia de Cartago, Costa Rica Edwards Lifesciences A tiempo completo

    Supervises employees responsible for Quality Inspection. **Key Responsibilities**: - Supervise employees and quality activities pertaining to the production of products and/or manufacturing processes in - and with quality/technical knowledge of 2 or more production areas, depending on the complexity of the areas, in addition to conducting performance...

  • Quality Engineer I

    hace 4 semanas

    Provincia de Cartago, Costa Rica Edwards Lifesciences A tiempo completo

    Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. **Key Responsibilities**: - Investigate basic manufacturing product quality and compliance issues (e.g., CAPA,...

  • Sr Quality Engineer

    hace 4 semanas

    Cartago, Costa Rica Terumo BCT A tiempo completo

    Título del puesto: Quality Engineer Puesto del gerente del área: Sr Manager Quality Responsabilidades principals Descripción del puesto: Tenga en cuenta que el texto de esta casilla debe pegarse en MySource y se utilizará para la publicidad interna/externa del puesto. Resumen de las funciones: Trabajando sin una dirección...

  • Sr Quality Engineer

    hace 2 días

    Cartago, Costa Rica Terumo BCT A tiempo completo

    Título del puesto: Quality Engineer Puesto del gerente del área: Sr Manager Quality Responsabilidades principals Descripción del puesto: Tenga en cuenta que el texto de esta casilla debe pegarse en MySource y se utilizará para la publicidad interna/externa del puesto. Resumen de las funciones: Trabajando sin una dirección...

  • Validation Engineer

    hace 4 semanas

    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 1 mes

    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...

  • Purchasing Engineer

    hace 4 semanas

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

    **Purchasing Engineer **Vacante Fresca****: Rau Precision Metals S.A. **Publicado el**: 18-04-2024, por Rau Precision Metals S.A.. **Descripción de la Empresa**: Manufactura. ACERCA DE LA VACANTE Funciones del Puesto - Purchase goods, materials, components or services in line with specified cost, quality and delivery targets of existing suppliers. -...

  • Quality Engineer Ii

    hace 4 semanas

    Provincia de Cartago, Costa Rica Edwards Lifesciences A tiempo completo

    Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. **Key Responsibilities**: - Investigate moderately complex manufacturing product quality and compliance issues...

  • Facility Project Engineer

    hace 5 días

    Provincia de Cartago, Costa Rica Coloplast A tiempo completo

    **Location**: Cartago, Costa Rica, CR **Job Family**: Manufacturing **Country/Region**: Costa Rica **Job Function Summary**: The Facilities Project Engineer is responsible for execution of critical infrastructure/equipment retrofits to CAR facility, including planning, scheduling, cost management and closeout. Also assist in the hiring and training of...

  • QMS Engineer Specialist

    hace 1 mes

    Cartago, Costa Rica Terumo BCT A tiempo completo

    Título del puesto: QMS Engineer Specialist Puesto del gerente del área: Quality system manager Responsabilidades principales Descripción del puesto: Tenga en cuenta que el texto de esta casilla debe pegarse en MySource y se utilizará para la publicidad interna/externa del puesto. Resumen de las funciones: Este puesto se...

  • Process Calibration Engineer

    hace 7 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 Process Calibration Engineer routinely ensures test of equipment and instruments to check that the reading and output meet expected results. If a deviation is found, Process Calibration Engineer will ensure that the equipment will...

  • Validation Technician

    hace 1 mes

    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...

  • Mgr Quality Operations

    hace 6 días

    Cartago, Costa Rica Terumo BCT A tiempo completo

    Job summary: Leads specified Quality Team supervising execution of key quality processes at the manufacturing facility. The Quality Operations Manager will play an integral role in ensuring the ability to produce a high-quality product, processes are aligned with regulations and standards which are aligned efficiently and compliantly with policies and...

  • Senior Quality Engineer

    hace 2 semanas

    Cartago, Costa Rica Nextern A tiempo completo

    This position is responsible for tactically managing quality requirements between Nextern and key customers, ensuring customer quality expectations and daily requirements in engineering, production development, and supply chain, balancing responsibility between areas to achieve product quality performance and in compliance with company requirements and...

  • Validation Engineer

    hace 3 semanas

    Cartago, Costa Rica Coloplast A tiempo completo

    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...

  • Production Engineer

    hace 5 días

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

    **Acerca de la vacante**: **Funciones 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...

  • Engineer I Mes

    hace 1 mes

    Provincia de Cartago, Costa Rica Edwards Lifesciences A tiempo completo

    Applies knowledge of technical principles and Edwards systems/procedures to optimize manufacturing processes. **Key Responsibilities**: - Improve manufacturing processes using engineering methods (e.g., LEAN methods, basic statistics) for continuous process improvement - Develop basic experiments and tests (including writing and executing protocols) to...

  • Technol, Facilities

    hace 1 semana

    Provincia de Cartago, Costa Rica Edwards Lifesciences A tiempo completo

    Provides preventative and corrective work in the maintenance of building and facilities systems, including clean room system, to ensure plant operations are not disrupted. **Key Responsibilities**: Daily Check and ensure the operation of BMS, PME, CMS and LSS Systems, Takes the appropriate actions in Case of Any Abnormalities/Critical active alarms. Takes...

  • Automation & Validation Engineer Ii

    hace 4 semanas

    Provincia de Cartago, Costa Rica Edwards Lifesciences A tiempo completo

    Drive the design, integration and implementation of global GSC manufacturing Process Control Network and automation systems throughout the production plant. **Key Responsibilities**: Digitize and automate portions of the manufacturing process and equipment, at the Edwards manufacturing facilities within project team, while focusing on process efficiency and...