Senior Quality Assurance Specialist

hace 2 semanas

Tijuana, Baja California, México Corza Medical A tiempo completo

Job Summary

The Senior Quality Engineer will be responsible for providing support and direction in quality assurance, control, and preventative activities with a focus on sustaining products. This role will manage the execution and changes in quality activities related to process development, verification, validation, and manufacturing transfer while ensuring compliance to regulations and standards.

Key Responsibilities

  • Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure that products are ideal and functional.
  • Monitor and maintain the quality system to comply with all applicable regulatory requirements including FDA QSRs, ISO, Medical Device Directive, and other applicable standards and/or guidelines.
  • Design and perform product testing and analysis to maintain quality levels and minimize defects and failure rates. Generate and analyze reports to determine trends and lead corrective actions.
  • Works closely with operations and the business functions to ensure quality performance of product and processes.
  • Maintains KPIs for monitoring of process and/or product quality, performs analysis, and interprets trends. Leads process improvements.
  • Review non-conformance reports and materials with production and engineering personnel to identify corrective actions.
  • Participates in the development and review of process and equipment validation/qualification and MSAs.
  • Executes internal quality deliverables associated with engineering changes, manufacturing transfers, and supplier-initiated changes.
  • Review manufacturing processes to develop preventive actions.
  • Direct the tracking and statistics of defects, test results, or other regulatory quality data.
  • Review and approve validation/qualification, Material Reports, and other QA documents for compliance with business practices and departmental procedures and policies.

Requirements

  • Degree in Engineering (Mechanical or Electrical preferred) or equivalent certification and work experience.
  • Minimum of 5+ years of working experience in engineering, quality, or manufacturing within a medical device company.
  • Strong validation understanding.
  • Automation background preferred.
  • Experience using MS Office Suite products (Word, Excel, PowerPoint, and Outlook).
  • Strong time management skills to ensure prioritization and organization to meet deadlines of multiple projects.
  • Experience problem-solving and lean principles.
  • Strong communication skills. Must be fluent in Spanish and English.

Work Environment

The Senior Quality Engineer is expected to be onsite at our Tijuana, Mexico site, Monday-Friday.

Corza Medical is an equal opportunity employer.

We evaluate qualified applicants without regard to race, color, marital status, religion, sex, sexual orientation, gender identity, age, national origin, physical or mental disability, veteran status, or other protected characteristics.

  • Quality Assurance Specialist

    hace 3 semanas

    Tijuana, Baja California, México North American Production Sharing A tiempo completo

    **Quality Assurance Specialist****Key Responsibilities:**1. Manage customer complaints and concerns to ensure timely resolution and improved customer satisfaction.2. Develop and implement quality improvement initiatives to drive business growth and excellence.3. Collaborate with cross-functional teams to design and implement effective quality control...

  • Senior Quality Assurance Specialist

    hace 7 días

    Tijuana, Baja California, México Enovis A tiempo completo

    Job Summary: We are seeking a Senior Quality Assurance Specialist to join our team at Enovis Corporation. The ideal candidate will have a strong background in quality assurance and a passion for developing and implementing quality systems.Key Responsibilities:Design and implement quality assurance protocols and methods for processing materials into partially...

  • Senior Quality Assurance Specialist

    hace 3 semanas

    Tijuana, Baja California, México Enovis A tiempo completo

    Job Summary:As a Senior Quality Assurance Specialist at Enovis, you will conduct complex quality analysis and testing of our quality control program, identifying areas for improvement and recommending changes to ensure the highest quality standards. You will also analyze customer claims, prepare reports on rejected or defective products, and assist in the...

  • Senior Quality Assurance Specialist

    hace 2 semanas

    Tijuana, Baja California, México Enovis A tiempo completo

    Job Title: Senior Quality Assurance Specialist - Orthopedic SolutionsAbout Enovis:Enovis Corporation (NYSE: ENOV) is a leading medical technology company dedicated to developing innovative solutions that drive better patient outcomes and streamline workflows.Our culture of continuous improvement, combined with a global talent pool and a strong commitment to...

  • Quality Assurance Specialist

    hace 3 semanas

    Tijuana, Baja California, México Medtronic A tiempo completo

    **Quality Assurance Role**We are seeking a Quality Assurance Specialist to join our team at Medtronic. As a Quality Assurance Specialist, you will be responsible for developing, modifying, and maintaining quality standards and protocols for processing materials into partially finished or finished materials products.**Key Responsibilities:**Collaborate with...

  • Quality Assurance Specialist

    hace 3 semanas

    Tijuana, Baja California, México Medtronic A tiempo completo

    Job SummaryWe are seeking a Quality Assurance Specialist to join our team at Medtronic. As a Quality Assurance Specialist, you will be responsible for developing, modifying, and maintaining quality standards and protocols for processing materials into partially finished or finished materials product.Key ResponsibilitiesDevelops, modifies, applies, and...

  • Quality Assurance Specialist

    hace 3 semanas

    Tijuana, Baja California, México Taskus A tiempo completo

    About the RoleWe are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team at TaskUs. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our services and identifying areas for improvement.Key ResponsibilitiesDevelop and implement quality assurance processes to ensure high-quality...

  • Quality Assurance Specialist

    hace 2 semanas

    Tijuana, Baja California, México Medtronic A tiempo completo

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Medtronic. As a Quality Assurance Specialist, you will be responsible for developing, modifying, and maintaining quality standards and protocols for processing materials into partially finished or finished materials products.Key Responsibilities:Develops, modifies,...

  • Senior Quality Assurance Specialist

    hace 3 semanas

    Tijuana, Baja California, México Vertiv A tiempo completo

    **Job Summary**We are seeking a highly skilled Senior Quality Assurance Specialist to lead our internal audit program and ensure compliance with our Quality Management System. The ideal candidate will have a strong background in quality management, excellent communication skills, and the ability to work independently.**Key Responsibilities**Develop and...

  • Senior Quality Assurance Specialist

    hace 1 semana

    Tijuana, Baja California, México Stryker Corporation A tiempo completo

    About the Role:The Senior Quality Assurance Specialist will play a critical role in ensuring the maintenance of the quality system to deliver products that meet customer specifications and applicable regulatory requirements. This position requires a detail-oriented individual with a passion for quality and a strong understanding of quality systems and...

  • Quality Assurance Specialist

    hace 2 semanas

    Tijuana, Baja California, México Autoliv Mexico A tiempo completo

    Quality Assurance Specialist at Autoliv MexicoAs a Quality Assurance Specialist at Autoliv Mexico, you will be responsible for ensuring the highest quality standards in our products and services. Your primary focus will be on quality point of contact for assigned OEM customer accounts, leading cross-functional problem-solving teams to investigate quality...

  • Quality Assurance Specialist

    hace 3 semanas

    Tijuana, Baja California, México Global Fidelis A tiempo completo

    Quality Control SpecialistGlobal Fidelis is seeking a highly skilled Quality Control Specialist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality in our apparel products.Key Responsibilities:Conduct thorough inspections of products, materials, and components to identify...

  • Senior Quality Assurance Specialist

    hace 3 semanas

    Tijuana, Baja California, México Corza Medical A tiempo completo

    Job SummaryWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Corza Medical. As a key member of our quality team, you will be responsible for ensuring the development, implementation, and maintenance of our Veeva System.Key ResponsibilitiesDevelop and implement strategies for maintaining CAPA and Audit Quality Programs...

  • Quality Assurance Specialist

    hace 2 semanas

    Tijuana, Baja California, México Enovis A tiempo completo

    Job Summary:We are seeking a Quality Assurance Specialist to join our team at Enovis. The successful candidate will be responsible for designing, implementing, and maintaining quality assurance protocols and methods for processing materials into partially finished or finished products.Key Responsibilities:Design and implement quality assurance protocols and...

  • Quality Assurance Specialist

    hace 2 semanas

    Tijuana, Baja California, México Carlisle Interconnect Technologies A tiempo completo

    Job SummaryWe are seeking a Quality Assurance Specialist to ensure the safety and quality of our products and procedures through rigorous inspections and implementation of quality control measures.Key ResponsibilitiesCollaborate with cross-functional teams to address quality issues and drive continuous improvement.Develop and execute test method validations,...

  • Senior Quality Assurance Specialist

    hace 3 semanas

    Tijuana, Baja California, México Eaton A tiempo completo

    Eaton's AER FED Fluid Electrical Distribution division is seeking a Senior Quality Assurance Specialist to execute the defined Strategic Quality Plan.**Key Responsibilities:**Align resources and evaluate their effectiveness to define actions to improve performance and exceed expectations. Drive continuous improvement in quality using the Eaton Business...

  • Quality Assurance Specialist

    hace 3 semanas

    Tijuana, Baja California, México Taskus A tiempo completo

    Job DescriptionAs a Quality Assurance Specialist at TaskUs, you will play a crucial role in ensuring the highest standards of quality in our client interactions. Your primary responsibility will be to analyze and improve our quality assurance processes, working closely with team leads and teammates to identify areas for improvement.Key responsibilities...

  • Quality Assurance Specialist

    hace 3 semanas

    Tijuana, Baja California, México Global Fidelis A tiempo completo

    Global Fidelis is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality control process, you will be responsible for ensuring the highest standards of quality in our apparel products.**Key Responsibilities:** Conduct thorough inspections of products, materials, or components to identify defects or deviations...

  • Quality Assurance Specialist

    hace 3 semanas

    Tijuana, Baja California, México Carlisle Interconnect Technologies A tiempo completo

    Job SummaryCarlisle Interconnect Technologies is seeking a Quality Assurance Specialist to ensure the safety and quality of our products and procedures through rigorous inspections and implementation of quality control measures. The ideal candidate will have a strong background in engineering or quality assurance and possess a proactive mindset.Key...

  • Quality Assurance Specialist

    hace 3 semanas

    Tijuana, Baja California, México Enovis A tiempo completo

    Job Description:We are seeking a Quality Assurance Specialist to join our team at Enovis. In this role, you will be responsible for designing, implementing, and maintaining quality assurance protocols and methods for processing materials into partially finished or finished products.About the Role:Design and implement quality assurance protocols and methods...