Senior Quality Engineer

hace 11 horas

Tijuana, Baja California, México Outset Medical, Inc. A tiempo completo

Position Overview:

The Quality Engineer will focus on development of Process Validation strategies, non-conformances, MRB, CAPA's, tracking and reporting on monthly basis and compiling and presenting data for management review, execution, and approvals of change orders.

Essential Job Functions and Responsibilities

Core Job

  • Manufacturing process sustaining (Cleanroom environment).
  • Sterilization concepts and product release.
  • Contractor´s management, such as external laboratories and sterilization sites.
  • Quality Inspectors management.

Supporting

  • NPI's activities from SJ Facility to MX facility by developing and executing the transfer validation strategy. (IQ, OQ or PQ)
  • Change orders for process improvements and determines when process stability and capability studies should be performed on existing processes.
  • Analyzes and performs failure analysis to non-conforming products.
  • Leads in the implementation of assurances, process controls, nonconformances and CAPA.
  • Reviews and participates in the update/creation process FMEA's, application FMEA's, and risk benefit analysis for medical devices.
  • Develops and prepares monthly quality trend analysis and reports.

Interpersonal skills

  • Leads, coaches, and mentors non-exempt and entry level exempt personnel.
  • A self-starter, motivated and able to positively motivate others.
  • Focused, target driven with a positive, can-do attitude.
  • Support additional activities, as assigned.

Required Qualifications

  • Bachelor's degree in engineering or technical field or equivalent experience is required.
  • Minimum of 5+ years of experience.
  • Knowledge of medical device regulations and standards such as 21 CFR 820, GMP, EN ISO 13485, and ISO 14971.
  • Able to read and understand technical data.
  • Competent using Microsoft Office suites.
  • Strong written and verbal communication in English.

Desired Qualifications

  • Good analytical, communication (both verbal and written) and presentation skills.
  • Statistical analysis software a plus.
  • Effective analytical, technical, and problem-solving skills.
  • Ability to multi-task and manage multiple assignments in a timely manner.
  • Strong analytical skills.
  • Quality engineering certification, Lean Six Sigma certification.

  • Senior Quality Engineer, Design

    hace 12 horas

    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 Design Quality Engineer

    hace 10 horas

    Tijuana, Baja California, México Outset Medical, Inc. A tiempo completo

    Position Overview:As a key member of the Quality Team, the incumbent will support quality activities related to the design, development, and reliability. The Senior Design Quality Engineer ensures that compliance to customer, risk management, quality, and Design Control requirements is demonstrated and helps to ensure successful transfer of the design to...

  • Quality Engineer

    hace 12 horas

    Tijuana, Baja California, México Gecko Alliance A tiempo completo

    At Gecko Alliance we design and deliver innovative solutions that power the spa and wellness industry.As a Quality Engineer, your role is key to ensure that our products and processes meet the highest standards of compliance, performance, and customer satisfaction.To perform this successfully you must demonstrate hands-on experience applying quality...

  • Quality Engineer

    hace 2 semanas

    Tijuana, Baja California, México Flex A tiempo completo

    Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every...

  • Product Quality Engineer

    hace 10 horas

    Tijuana, Baja California, México Sercomm A tiempo completo

    Job Opportunity – Product Quality Assurance (PQA) Engineer / Section ManagerWe are looking for a highly motivated Product Quality Assurance (PQA) Engineer / Section Manager to join our team.This role offers exciting opportunities for career growth and development, as well as the chance to collaborate with international teams from Taiwan, China, the...

  • Principal Quality Engineer

    hace 10 horas

    Tijuana, Baja California, México Haemonetics 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 DetailsThe Principal Quality Engineer plans, conducts, and directs engineering projects or studies including complete projects...

  • Project Quality Engineer

    hace 11 horas

    Tijuana, Baja California, México Autoliv A tiempo completo

    Project Quality EngineeWhat You'll DoProject Quality is the voice of the Plant and manufacturing process within AS100 projects, in charge of leading and understanding AS100 Quality tasks. As a member of the AS100 CFT from TG0 to TG4 located in the plant, Project Quality is responsible that the product and manufacturing process are developed together in a...

  • Senior Quality Engineer

    hace 11 horas

    Tijuana, Baja California, México Outset Medical A tiempo completo

    Company OverviewJoin us for an enriching journey with Outset, a trailblazing medical device company that is revolutionizing the field of dialysis. Our focus is to create one high performing team, obsessed with progress, in an atmosphere that is brimming with transformative opportunities. The heart of our mission is pioneering a groundbreaking technology that...

  • Senior Supply Quality Engineer

    hace 12 horas

    Tijuana, Baja California, México Roku A tiempo completo

    Teamwork makes the stream work.Roku is changing how the world watches TVRoku is the #1 TV streaming platform in the U.S., Canada, and Mexico, and we've set our sights on powering every television in the world. Roku pioneered streaming to the TV. Our mission is to be the TV streaming platform that connects the entire TV ecosystem. We connect consumers to the...

  • Senior Packaging Engineer

    hace 11 horas

    Tijuana, Baja California, México ICU Medical A tiempo completo

    Position SummaryThe Senior Packaging Engineer is responsible for supporting and driving packaging related projects through adherence to established quality system requirements, design control processes, good engineering, and documentation practices. The key responsibility of this position is to exercise medical device packaging subject matter expertise,...