Prin Engr, Quality Systems

hace 5 meses


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, 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 Engineering or Scientific field, 2 years of experience minimum, 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 18,500 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 States Applicants Only**:
Edwards i


  • Engr I, Quality

    hace 5 meses


    Provincia de Cartago, Costa Rica Edwards Lifesciences A tiempo completo

    Supervise employees and activities across areas of quality. **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...

  • Engr I, Facilities

    hace 6 meses


    Provincia de Cartago, Costa Rica Edwards Lifesciences A tiempo completo

    Ensure smooth operation of facilities and building systems in Costa Rica manufacturing plant. This position maintain one or more of the following facility systems as assigned by supervisor: Process water system, HVAC system, clean room system, boiler system, incoming power, water supply, air compressed system, building maintenance, fire protection system,...

  • Engr I

    hace 6 meses


    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...

  • Engr Ii

    hace 6 meses


    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**: - Optimize manufacturing processes, including using engineering methods (e.g., SIX Sigma and LEAN methods) for continuous process improvement and/or re-design/design of equipment, tools, fixtures, etc. to improve...

  • Engr I

    hace 6 meses


    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...


  • Provincia de Cartago, Costa Rica Boston Scientific Corporation A tiempo completo

    **Work mode**:Onsite**Onsite Location(s)**:Cartago, CR**Additional Locations**: N/A**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...


  • Provincia de Cartago, Costa Rica Boston Scientific Corporation A tiempo completo

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


  • Provincia de Cartago, Costa Rica Edwards Lifesciences A tiempo completo

    Develop, create, and implement IT processes and policies as it relates to Change Management/Control, Compliance, Governance, and Vendor Management. Analyze and determine the appropriate course of action for non-compliance/conformance deviations **Key Responsibilities**: - Leads and provides guidance in developing, creating, and implementing IT processes...

  • Quality Engineer

    hace 5 meses


    Provincia de Cartago, Costa Rica Coloplast A tiempo completo

    **Location**: Cartago, Costa Rica, CR **Job Family**: Quality Assurance **Country/Region**: Costa Rica Our 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 and maintain quality...


  • Provincia de Cartago, Costa Rica Boston Scientific Corporation A tiempo completo

    **Work mode**:Onsite**Onsite Location(s)**:Cartago, CR**Additional Location(s)**: Costa Rica-Coyol**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...


  • Provincia de Cartago, Costa Rica Edwards Lifesciences A tiempo completo

    Develops, implements, and sustains IT solutions to business problems to improve business processes, develop systems and policies, improve user proficiency, and promote system adoption in collaboration with key stakeholders. **Key Responsibilities**: - Performs root cause analysis and troubleshoot business systems, interfaces, configurations, etc.,...


  • 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 Incoming Quality Assistant I has the responsibility of ensuring that incoming raw materials are released on time by ensuring to check the Certificate of Analysis / Certificate of Conformity supplied by the supplier and that...


  • Provincia de Cartago, Costa Rica Edwards Lifesciences A tiempo completo

    Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for...


  • Provincia de Cartago, Costa Rica Coloplast A tiempo completo

    **Location**: Cartago, Costa Rica, CR **Job Family**: Quality Assurance **Country/Region**: Costa Rica Our Supplier Quality Team Leader manages and leads the daily work together with the subordinate jobs related to supplier quality and incoming process activities and ensures quality control of raw material supply to the production, as well as with direct...

  • Engineer Ii, Quality

    hace 6 meses


    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...


  • Provincia de Cartago, Costa Rica Edwards Lifesciences A tiempo completo

    Innovation starts from the heart. At Edwards Lifesciences, we’re dedicated to developing ground-breaking technologies with a genuine impact on patients’ lives. At the core of this commitment is our investment in cutting-edge information technology. This supports our innovation and collaboration on a global scale, enabling our diverse teams to optimize...


  • Cartago, Costa Rica Nextern A tiempo completo

    The Quality System Engineer will be responsible for maintaining and implementing process improvements to Nextern’s Global Quality System (QMS) procedures including supporting software configuration (Agile PLM). This position will also be responsible for supporting internal audits, data analysis, training, and implementation of Quality System Software...


  • Provincia de Cartago, Costa Rica Boston Scientific Corporation A tiempo completo

    **Work mode**:Onsite**Onsite Location(s)**:Cartago, CR**Additional Locations**: N/A**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...

  • Quality Engineer Ii

    hace 6 meses


    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...


  • 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...