Process Quality Engineer

hace 4 días

Heredia, Costa Rica Bayer A tiempo completo

**Process Quality Engineer**

**TASKS AND RESPONSIBILITIES**

Quality System:

- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- Represent Quality by supporting quality disciplines, decisions, and practices.
- Adhere to the Quality Management System. Review/analyze whether current product and processes (including actions or decisions conducted) comply to standards such as FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements, as well as best industry practices.
- Be knowledgeable on QSR and ISO/MDD standards, constantly promoting awareness of applicable Global Regulations and standards, making appropriate decisions on a daily basis.
- Support and prepare for site level internal/external audits and act as Subject Matter Expert (SME) in audits.

In process Quality:

- Provide direct support to ongoing manufacturing of products by identifying and implementing effective process control systems that meet or exceed internal and external requirements, and which are consistent with the level of process/product risk.
- Lead process control and monitoring of CTQ parameters and specifications.
- Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes. Develop, interpret, and implement standard and non-standard sampling plans.
- Have the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
- Work closely with Manufacturing and other support functions to troubleshoot during unexpected events.
- Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process controls.
- Conduct evaluations and oversight of production personnel and processes to ensure procedures are being followed in accordance with GMP compliance and regulatory guidelines.
- Participate in Customer Complaints investigations for areas under your control.
- Recommend improvements to the production process to ensure quality control.

New Products and Processes:

- Support the development of quality strategies related to the development of new products, materials and component and the transfer to production through cross functional team collaboration, understanding technical requirements, supporting qualification, and ensuring adherence to the quality system and regulatory requirements.
- Provide guidance with and Review/Approve URS, IQ, OQ, PQ, TMV and/or Software Validation.
- Perform validation activities as needed. Appropriately document experiment plans and results, including protocol writing and reports.
- Summarize analyze and draw conclusions from test results/ process related findings and make appropriate decisions.
- Promote the creation of quality plans due to technology transfer projects, validations and significant changes in the QMS as applicable.
- Establish guidance and maintain Documented Quality Plans to ensure a timely and controlled implementation of product developments, improvement projects and subcontracted manufacturing activities.

Corrective and Preventive action:

- Lead corrective and preventive action (CAPA) projects using root cause analysis as well as identifying and implementing robust solutions.
- Lead the prevention of product and process nonconformances.
- Conduct Risk based decision making and effective resolution of issues.

Process Improvement:

- Continually seek to drive improvements in product and process quality.
- Identify and drive continuous improvement projects and quality initiatives by partnering and communicating effectively with various functions.
- Identify and implement effective process control systems to support the development, qualification, and on going manufacturing of products to meet or exceed internal and external requirements.
- Conduct benchmarking to develop more effective methods for improving quality Pro actively investigates, identifies and implements best in class Quality Engineering practices and implements/manage improvement projects within the organization.
- Assist in the development and execution of streamlined business systems, which effectively identify and resolve quality issues.
- Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
- Use Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.

Risk Management:

- Document, justify, review, or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential noncompliance to a required standard such as ISO 13485.
- Lead in the completion and maintenance of risk analysis.
- Develop control plans consistent with product classification, p

  • Quality Engineer Iii

    hace 4 semanas

    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 Assistant

    hace 3 semanas

    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,...

  • Engineer Ii, Quality

    hace 4 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 1 día

    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...

  • Quality Engineer Assistant

    hace 3 semanas

    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,...

  • Engineer Sr, Process

    hace 3 semanas

    Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

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

  • Process Engineer Iii

    hace 4 semanas

    Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Work mode**:Onsite**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 4 semanas

    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...

  • Process Engineer

    hace 3 semanas

    Heredia, Costa Rica AlignTech A tiempo completo

    **Join a team that is changing millions of lives.** - Transforming smiles, changing lives_ At Align Technology, we believe a great smile can transform a person’s life, so we create technology that gives people the confidence to take on whatever’s next. We revolutionized the orthodontic industry with the introduction of the Invisalign system, and we have...

  • Quality Engineer

    hace 2 semanas

    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 Ii

    hace 5 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...

  • Process Engineer Entry

    hace 3 semanas

    Heredia, Costa Rica Equifax A tiempo completo

    Equifax is where you can power your possible. If you want to achieve your true potential, chart new paths, develop new skills, collaborate with bright minds, and make a meaningful impact, we want to hear from you. In this role you will have the exciting opportunity of making an impact on company process by: Being responsible for planning, monitoring and...

  • Quality Process Consultant

    hace 4 semanas

    Heredia, Costa Rica Equifax A tiempo completo

    Equifax is where you can power your possible. If you want to achieve your true potential, chart new paths, develop new skills, collaborate with bright minds, and make a meaningful impact, we want to hear from you. This role is responsible for assisting with the design of a business process quality & risk framework for businesses located in the US. This...

  • Web Quality Assurance Engineer

    hace 2 semanas

    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...

  • Quality Engineer Ii, Heredia Turno C

    hace 2 semanas

    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 B

    hace 2 semanas

    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...

  • Engineer Ii, Supplier Quality

    hace 1 semana

    Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Engineer II, Supplier Quality**: - Remote Eligible: Hybrid- Onsite Location(s): Heredia, H, CR**Additional Location(s)**: 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...

  • Junior Process Engineer

    hace 2 semanas

    Heredia, Costa Rica Straumann Group A tiempo completo

    **#ChangeMakers** **Ready to make an impact?** We develop, manufacture, and supply dental implants, clear aligners, instruments, CADCAM prosthetics and biomaterials for use in esthetic dentistry, tooth replacement and restoration solutions or to prevent tooth loss. We empower our employees to perform and make an impact, to question the status quo, to...

  • Senior Quality Engineer

    hace 4 semanas

    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...

  • Quality Engineer Junior Temporary

    hace 3 semanas

    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...