Sr. Design Quality Engineer

hace 7 días

Tijuana, México Haemonetics Corp. A tiempo completo

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.

Job Details

Senior Design Quality Engineer is accountable to support the quality system by ensuring compliance to and enforcing regulations, standards, policies, standard operating procedures, and instructions related to design control. The Senior Design Quality Engineer will work as a member of the cross-functional design team supporting new product development and sustaining engineering change management.

SUPPORT NEW PRODUCT DEVELOPMENT & PRODUCT CHANGE MANAGEMENT BY:

- Represent Quality department as cross-functional team member for product portfolios, new product development projects,

and product change projects
- Manage project quality plans
- Lead or participate in translation of Voice-of-Customer into development Requirements
- Support development team in creation, review, and approval of engineering Requirements & Specifications in accordance

with standard operating procedures
- Lead cross-functional teams in the development, update, and release of risk management documentation inclusive of but

not limited to: Hazard Analysis, Risk Management Plan & Report, FMEA’s (Use, Design & Process), Fault Tree Analysis (FTA)
- Lead or support development team in creation, review, and approval of engineering development plans & test plans
- Support development team in creation, review and approval of engineering test protocols and reports in support of design

verification, design validation, and process validation
- Lead the development team in creation, review, and approval of critical-to-quality specifications
- Support development team in creation, review, and approval of traceability of user requirements, engineering

specifications, and verification & validation testing
- Lead measurement systems analysis for acceptability and develop, support, & approve validation protocols and reports for

test methods
- Define statistical testing methods and sampling in support of verification and validation testing
- Ability to support any Product Line Portfolios and actively supports 1 or more Product Line Portfolios
- Ensure accuracy and completeness of the Design History File and the Device Master Record
- Compile, review, and analyze failure data to provide feedback to the development team
- Mentor, develop, coach, and / or supervise less experienced quality engineers
- SUPPORT QUALITY SYSTEM BY:

- Ensuring compliance to and enforcement of all required elements from regulations, standards, policies, standard
- Supporting and administering quality system elements including but not limited to: Design Controls, CAPA, Non
- Conformance, Complaint, Deviation, Document Controls, Labeling, etc.
- Lead continuous improvement projects and reviews of policies, procedures, instructions, and training
- Ensure the ongoing readiness for and participate in any potential internal/external audits and inspections
- Lead or participate in problem solving and other work improvement activities

LI-JC1
- EEO Policy Statement

  • Sr. Quality Engineer

    hace 1 semana

    Tijuana, México Ensambles Hyson, S.A. de C.V. A tiempo completo

    Descripción y detalle de las actividadesOverview The Sr. Quality Engineer will be responsible to provide quality support and the development of manufacturing processes for molding areas. Responsibilities This individual will be responsible to provide quality support and the development of manufacturing processes for molding areas. The engineer will use...

  • Senior Quality Engineer, Design

    hace 4 semanas

    Tijuana, México ICU Medical A tiempo completo

    Direct message the job poster from ICU MedicalHuman Resources Professional, SHRM-CP, HRBPPosition SummaryProvide quality support for ICU Medical Product and Development and design changes. The Sr. Quality Engineer will be responsible for development procedures and deliverables, ensuring their compliance with ICU Medical quality system requirements and...

  • Senior Quality Engineer, Design

    hace 4 semanas

    Tijuana, México ICU Medical A tiempo completo

    Direct message the job poster from ICU MedicalHuman Resources Professional, SHRM-CP, HRBPPosition SummaryProvide quality support for ICU Medical Product and Development and design changes. The Sr. Quality Engineer will be responsible for development procedures and deliverables, ensuring their compliance with ICU Medical quality system requirements and...

  • Sr Quality Engineer

    hace 2 semanas

    Tijuana, México Icu Medical Tijuana A tiempo completo

    Descripción y detalle de las actividadesThe Sr.Quality Engineer will be responsible for development procedures and deliverables, ensuring their compliance with ICU Medical quality system requirements and applicable regulations and standards (such as ISO *****, ISO *****, 21 CFR Part 820, and other applicable regulations and standards).The Sr.Quality...

  • Senior Quality Engineer, Design

    hace 1 semana

    Tijuana, Baja California, México ICU Medical A tiempo completo

    Position SummaryProvide quality support for ICU Medical Product and Development and design changes. The Sr. Quality Engineer will be responsible for development procedures and deliverables, ensuring their compliance with ICU Medical quality system requirements and applicable regulations and standards (such as ISO 13485, ISO 14971, 21 CFR Part 820, and other...

  • Senior Quality Engineer, Design

    hace 2 semanas

    Tijuana, México Icu Medical A tiempo completo

    Direct message the job poster from ICU MedicalHuman Resources Professional, SHRM-CP, HRBPPosition SummaryProvide quality support for ICU Medical Product and Development and design changes.The Sr.Quality Engineer will be responsible for development procedures and deliverables, ensuring their compliance with ICU Medical quality system requirements and...

  • Sr Customer Quality Engineer

    hace 3 semanas

    Tijuana, México North American Production Sharing A tiempo completo

    **Sr. Customer Quality Engineer****Essential responsibilities**:- 1- Handle customer complaints- 2- Track and communicate progress in Quality Improvements- 3- Develop tools to effectively track performance- 4- Communicate with customers to update on complaints- 5- Make presentations on Quality KPIs to Upper Management.- 6- Train employees in WCM Quality...

  • Sr. Quality Engineer

    hace 2 semanas

    Tijuana, México Emprego MX A tiempo completo

    Descripción y detalle de las actividades This Sr. Quality Engineer will ensure compliance throughout the organization on major programs from product design through manufacturing and product support. Assign tasks to and direct engineers, technicians and inspectors staff. Plan and coordinate detailed aspects of the Quality Assurance / Quality Engineering...

  • Sr. Supplier Quality Engineer

    hace 4 días

    Tijuana, México Bose A tiempo completo

    You know the moment. It’s the first notes of that song you love, the intro to your favorite movie, or simply the sound of someone you love saying “hello.” It’s in these moments that sound matters most.At Bose, we believe sound is the most powerful force on earth. We’ve dedicated ourselves to improving it for nearly 60 years. And we’re passionate...

  • Sr. Supplier Quality Engineer

    hace 4 días

    Tijuana, México Bose A tiempo completo

    You know the moment. It’s the first notes of that song you love, the intro to your favorite movie, or simply the sound of someone you love saying “hello.” It’s in these moments that sound matters most.At Bose, we believe sound is the most powerful force on earth. We’ve dedicated ourselves to improving it for nearly 60 years. And we’re passionate...