Senior Quality Assurance Engineer

hace 4 semanas


Monterrey, Nuevo León, México Baxter A tiempo completo

**Transforming Healthcare through Quality and Innovation**

Baxter is a leading medical technology company that has been pioneering significant medical innovations for over 85 years. Our mission is to save and sustain lives, and we are committed to delivering high-quality products and therapies that improve outcomes for millions of patients worldwide.

As a Principal Engineer - Product Quality/Design Assurance, you will be an embedded partner member in R&D project teams, responsible for ensuring the sustainment of sophisticated medical device projects on time with the highest quality and product safety. You will participate in various Design Assurance improvement initiatives to improve the overall quality of new product designs and the company's regulatory compliance profile.

**Key Responsibilities:**

  • Ensure Design Assurance functions as a core team member on sustaining engineering teams, ensuring compliance with all portions of Design Control and related Quality System elements.
  • Prepare, manage, and/or update all Design Assurance required sustaining engineering deliverables, and support the remainder of the team in developing a quality product that meets regulatory requirements.
  • Responsible for ensuring product development activities related to verification and validation are fully compliant to the quality system procedures.
  • Assist in identification and mitigation of product or process-related risks.
  • Support the CAPA and FA process by performing investigations, root cause analyses, and verification of effectiveness checks for design-related issues impacting the field. Support internal and external regulatory and customer audits.

**Requirements:**

  • B.S. in Engineering, preferably Mechanical, Electrical, Electronics, or Computer Engineering.
  • 5+ years' experience in medical device or other regulated technical industry (e.g., aerospace, automotive, defense) in a design/development/quality role desired.
  • Product Design experience may be considered in lieu of Quality Assurance experience.
  • Knowledge of Quality System Regulations, Medical Device Directive, and ISO Quality System Standards.
  • Knowledge of 21 CFR 820.30, ISO13485, IEC62304 desirable.
  • Knowledge of EN ISO 14971:2012; safety by design; Risk Management structure desirable.
  • Ability to perform and influence in cross-functional team environments and utilize effective interpersonal skills.


  • Monterrey, Nuevo León, México Acuity Brands Lighting, Inc A tiempo completo

    Job SummaryAcuity Brands Lighting, Inc is seeking a Senior Quality Assurance Engineer to join our team. The ideal candidate will have a strong background in quality assurance and a passion for ensuring products meet customer expectations.Key ResponsibilitiesDevelop and implement quality plans to ensure products meet customer specificationsCollaborate with...

  • Senior Quality Engineer

    hace 3 semanas


    Monterrey, Nuevo León, México Ntt Data A tiempo completo

    **Job Title:** Senior Quality EngineerWe are seeking a Senior Quality Engineer to work with our team in Mexico City, Mexico.About the Role:The Senior Quality Engineer will be responsible for ensuring the quality of our software products and services.Key Responsibilities:Develop and implement quality assurance processes and procedures.Collaborate with...


  • Monterrey, Nuevo León, México Bosch Group A tiempo completo

    At Bosch, we are seeking a skilled Senior Quality Assurance Engineer to join our team in ensuring the highest quality of our products. As a key member of our quality control team, you will be responsible for conducting rigorous testing and analysis of materials in our laboratory.Key responsibilities include:Conducting coating, chemical, and mechanical...


  • Monterrey, Nuevo León, México Dataart A tiempo completo

    Job Title: Senior Software Quality Assurance EngineerAbout the Role:As a Senior Software Quality Assurance Engineer at Dataart, you will play a crucial role in ensuring the quality and reliability of our software products. Reporting to the VP of Engineering Quality, you will be responsible for testing and validating our software to meet the highest standards...


  • Monterrey, Nuevo León, México Polaris Inc. A tiempo completo

    About the RoleWe are seeking a highly skilled Quality Assurance Engineer to join our team at Polaris Inc. This is a fantastic opportunity for an experienced professional to take on a challenging role and make a significant impact on our quality control processes.As a Quality Assurance Engineer, you will be responsible for ensuring that our products meet the...


  • Monterrey, Nuevo León, México Dematic A tiempo completo

    We are seeking a talented Senior Quality Assurance Engineer to provide benchmark support for our 4 operations in the Americas region.You will work closely with customers and other engineers to develop and maintain our Quality System.Key responsibilities include:Developing, implementing, and maintaining a Quality Management System for business needsManaging a...


  • Monterrey, Nuevo León, México Lenovo A tiempo completo

    About the RoleWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Lenovo. In this role, you will be responsible for driving daily adherence to the Quality Management System and Operation Excellence subject matter expert.Key ResponsibilitiesDrive quality improvement efforts to enforce an effective Quality Management System...


  • Monterrey, Nuevo León, México Polaris Inc. A tiempo completo

    Job OverviewWe are seeking a highly skilled and experienced Quality Assurance Engineer to join our team at Polaris Inc. This is an exciting opportunity for a motivated professional to take on a challenging role that involves designing and implementing quality control processes, ensuring the highest standards of product quality.


  • Monterrey, Nuevo León, México Jabil Circuit A tiempo completo

    At Jabil, we strive to make anything possible and everything better. With over 50 years of experience across industries and a vast network of over 100 sites worldwide, we combine global reach with local expertise to deliver both scalable and customized solutions.**Job Overview**We are seeking a Senior Quality Assurance Engineer to assist the Quality...


  • Monterrey, Nuevo León, México Carrier A tiempo completo

    Job Description: We are seeking a highly motivated and results-driven Senior Software Quality Assurance Engineer with expertise in embedded systems to join our Commercial Controls Engineering team. As a key member of our team, you will be responsible for ensuring the quality and reliability of embedded software solutions through rigorous testing and...


  • Monterrey, Nuevo León, México International Automotive Components A tiempo completo

    The IAC Group is a dynamic, high-energy environment that seeks a skilled associate with exceptional analytical and communication skills.We are looking for talented professionals who want to build a successful career in quality assurance as Senior Quality Assurance Specialist - Manufacturing.**Job Description**:Create and implement quality programs to assess...


  • Monterrey, Nuevo León, México Vertiv Co A tiempo completo

    About the RoleAs a Principal Quality Assurance Engineer at Vertiv Co, you will play a key role in ensuring the quality of our software meets product requirements. This is an exciting opportunity to join our team and contribute to the development of cutting-edge technology.


  • Monterrey, Nuevo León, México Carrier A tiempo completo

    Job SummaryCarrier is seeking a highly skilled Senior Embedded Software Quality Assurance Engineer to join our Commercial Controls Engineering team. As a key member of our team, you will be responsible for ensuring the quality and reliability of our embedded software solutions through rigorous testing and analysis.Key ResponsibilitiesDevelop and execute...


  • Monterrey, Nuevo León, México STERIS IMS A tiempo completo

    STERIS IMS is seeking a Senior Quality Assurance Specialist to play a key role in maintaining and improving the quality system in accordance with regulatory requirements. As a Senior Quality Assurance Specialist, you will be responsible for supporting complaint and corrective action investigations, supplier quality improvement, and product and service...


  • Monterrey, Nuevo León, México Weir A tiempo completo

    Company Overview:Weir is a world-leading engineering business dedicated to making mining operations smarter, more efficient, and sustainable. Founded in 1871, our purpose is to power a low-carbon future by providing innovative solutions for the metals and minerals industry.Compensation: This role offers a competitive salary of $95,000 per year, with...


  • Monterrey, Nuevo León, México Epicor Software Corporation A tiempo completo

    About the Role: We're seeking a skilled Senior Quality Assurance Engineer to refine our ERP application through robust Software Quality Assurance. As a key member of our dynamic team, you'll play a pivotal role in enhancing pipelines and driving efficiency.Key Responsibilities:Execute test cases with precision, meticulously documenting outcomes.Collaborate...


  • Monterrey, Nuevo León, México Trigo Global Quality Solutions A tiempo completo

    **Job Summary:**We are seeking a highly skilled Senior Quality Consultant to lead our vehicle test engineering team.**Key Responsibilities:**Coordinate and design standard and unique tests for vehicle quality assurance.Lead a team of test engineers to ensure high-quality test results.Collaborate with cross-functional teams to identify and implement quality...


  • Monterrey, Nuevo León, México Infosys Limited A tiempo completo

    Job RequirementsWe are seeking a highly skilled Senior Software Quality Assurance Engineer to join our team at Infosys Limited.Key Responsibilities:Design and execute comprehensive testing strategies to ensure the highest quality of software products.Collaborate with cross-functional teams to identify and prioritize testing needs.Develop and maintain test...


  • Monterrey, Nuevo León, México Deere A tiempo completo

    Quality Assurance for Welding ExcellenceAt Deere, we're committed to delivering high-quality products that meet our customers' expectations. As a Senior Welding Quality Engineer, you'll play a key role in ensuring the quality of our welded components. Your expertise will be instrumental in developing and implementing quality planning, control, and...


  • Monterrey, Nuevo León, México ZF Group A tiempo completo

    About the RoleWe are seeking a highly skilled Quality Assurance Engineer to join our team at ZF Group. As a key member of our supplier development team, you will be responsible for ensuring the highest quality standards in our supply chain.ResponsibilitiesDevelop and implement quality management systems to ensure compliance with ZF specifications and...