Quality Assurance Engineer

hace 1 mes

Juárez, Chihuahua, México Integer Holdings Corporation A tiempo completo
Job Title: QA Eng I

At Integer, we are committed to creating a culture that unifies and positions us for long-term success. As a QA Eng I, you will play a critical role in supporting the administration of our Quality Management System and ensuring compliance with established standards, client, and medical devices industry requirements.

Key Responsibilities:
  • Coordinate the Internal Audit Process and participate in customer and notify body audits, including audit responses.
  • Ensure all associated documentation and procedures are in compliance, including trending and reporting of these activities.
  • Administer Quality Management System for compliance with ISO 13485, 21 CFR Part 820, COFPERIS, Japan, and Brazil, and GMP regulatory requirements related to medical devices industry.
  • Act as Lead Auditor or team member and coordinate audits activities with team members, including review of audit reports and provide technical assistance.
  • Review audit results with coordinator and other assessment team members to verify and document evidence of compliance to ensure audit findings are solved.
  • Coordinate audit meetings and follow up of CAPAs and audit findings.
  • Provide management with updates on status of work, initiatives, and projects as required.
  • Liaison with client regarding audit activities.
  • Participate actively in CAPA Process and support on KPI reports.
  • Administer and control quality records according to retention period established and maintain a clean and organized work area.
Requirements:
  • Microsoft Office experience (word, outlook, excel).
  • Minimum 3 to 5 years' experience in GMP Audits in the medical device industry.
  • Medical Device Quality System Knowledge Including 21 CFR Part 820 (QSR) & ISO 13485.
  • Root Cause Analysis and Investigations experience.
  • English language.
  • Strong communication skills (verbal, written, and presentation).
  • Must have good interpersonal and negotiation skills.
  • Must have experience and working knowledge in the Quality discipline, Medical Device manufacturing.

It is impossible to list every requirement for, or responsibility of, any position. Similarly, we cannot identify all the skills a position may require since job responsibilities and the Company's needs may change over time. Therefore, the above job description is not comprehensive or exhaustive. The Company reserves the right to adjust, add to, or eliminate any aspect of the above description. The Company also retains the right to require all employees to undertake additional or different job responsibilities when necessary to meet business needs.

U.S. Applicants: EOE/AA Disability/Veteran

  • Quality Assurance Engineer

    hace 4 semanas

    Juárez, Chihuahua, México Bosch Group A tiempo completo

    **About the Role**We are seeking a highly skilled Quality Assurance Engineer to join our team at Bosch Group.As a Quality Assurance Engineer, you will be responsible for ensuring the quality of our manufacturing processes and products.**Key Responsibilities**:Enable compliance of quality requirements of Series productions and manufacturing process by the use...

  • Quality Assurance Engineer

    hace 4 semanas

    Juárez, Chihuahua, México Integer Holdings Corporation A tiempo completo

    At Integer, we are seeking a Quality Assurance Engineer to support the administration of our Quality Management System.The ideal candidate will have a strong background in GMP audits and medical device quality systems, including 21 CFR Part 820 and ISO 13485.Responsibilities will include coordinating internal audits, participating in customer and notify body...

  • Quality Assurance Engineer

    hace 3 semanas

    Juárez, Chihuahua, México Flex Ltd A tiempo completo

    At Flex Ltd, we're looking for a talented Quality Assurance Engineer to join our team.This is an exciting opportunity to work with our extraordinary teams who build great products and contribute to our growth.The Quality Assurance Engineer will be responsible for:Developing and implementing standards and methods for inspection, testing and...

  • Quality Assurance Engineer II

    hace 4 semanas

    Juárez, Chihuahua, México Integer A tiempo completo

    At Integer, we strive to create a culture that unifies and positions the company for long-term success.We focus on our customers' success and create better solutions through innovation and collaboration.Our values are embedded in everything we do, including customer satisfaction, innovation, collaboration, inclusion, candor, and integrity.We are seeking a...

  • Senior Quality Assurance Engineer

    hace 4 semanas

    Juárez, Chihuahua, México Johnson & Johnson Sa De Cv A tiempo completo

    **Quality Assurance Senior Role at Johnson & Johnson Sa De Cv**We are seeking a highly skilled Senior Quality Assurance Engineer to join our team at Johnson & Johnson Sa De Cv. As a Senior Quality Assurance Engineer, you will be responsible for planning, conducting, and directing engineering projects or studies, including complete projects that require...

  • Quality Assurance Engineer with Compliance Expertise

    hace 5 días

    Juárez, Chihuahua, México Cordis A tiempo completo

    Cordis is seeking a highly skilled Quality Assurance Engineer to join our team. The successful candidate will have a strong background in quality assurance and compliance, with experience in the medical device industry.As a Quality Assurance Engineer at Cordis, you will be responsible for investigating customer complaints, identifying root causes, and...

  • Software Quality Assurance Engineer

    hace 4 semanas

    Juárez, Chihuahua, México Medtronic A tiempo completo

    Job SummaryWe are seeking a highly skilled Software Quality Assurance Engineer to join our team at Medtronic. As a key member of our software development team, you will be responsible for ensuring the quality and reliability of our software products.Key ResponsibilitiesPerform workflow analysis and document test results to recommend quality improvements.Work...

  • Quality Assurance Engineer for Medical Devices

    hace 6 días

    Juárez, Chihuahua, México Johnson And Johnson A tiempo completo

    OverviewJohnson & Johnson, a world leader in healthcare innovation, is seeking a highly skilled Quality Assurance Engineer for Medical Devices to join our team in Juárez, Mexico.

  • Senior Quality Assurance Engineer

    hace 4 semanas

    Juárez, Chihuahua, México Trackonomy A tiempo completo

    **Trackonomy's Quality Assurance Vision**We are seeking a highly skilled and experienced Senior Quality Assurance (QA) Engineer to join our innovative team. As a Senior QA Engineer, you will be instrumental in ensuring the quality and reliability of our cutting-edge products. You will lead the design and execution of quality testing strategies for concurrent...

  • Quality Assurance Engineer

    hace 22 horas

    Juárez, Chihuahua, México Wistron México A tiempo completo

    About Wistron MexicoWistron Mexico is a leading electronics manufacturer with a great opportunity for you as Quality Assurance Engineer (2nd Shift).Estimated Salary Range:$1,000 - $2,000 per month.Job Description:We are looking for a skilled Quality Assurance Engineer to oversee the quality control stages in our production line. As a key member of our team,...

  • Quality Assurance Specialist

    hace 3 semanas

    Juárez, Chihuahua, México Bosch A tiempo completo

    Job Description:As a key member of our Quality Assurance team at Robert Bosch Ciudad Juarez Mexico, the Technical Quality Engineer will be responsible for ensuring the highest quality standards in our suppliers' products and processes. The ideal candidate will have a strong background in mechanical engineering and extensive experience in Quality Assurance in...

  • Senior Quality Assurance Engineer

    hace 4 días

    Juárez, Chihuahua, México Mc Tool A tiempo completo

    About the RoleAt Mc Tool, we are seeking a highly skilled Senior Quality Assurance Engineer to join our team. In this role, you will be responsible for ensuring that our products meet the highest standards of quality.Key ResponsibilitiesManage metrology equipment, including CMM and VMM, and create and execute programs using MCOSMOS/PCDMIS software.Ensure...

  • Senior Quality Assurance Engineer

    hace 4 días

    Juárez, Chihuahua, México Tecma A tiempo completo

    At Tecma, we are seeking a highly skilled Senior Quality Assurance Engineer to join our team. This is a full-time position that requires a minimum of 5-10 years of experience in quality management.Job SummaryWe are looking for a talented professional with a strong background in mechanical, electrical or manufacturing engineering, and Six Sigma black-belt...

  • Quality Assurance Engineer

    hace 3 semanas

    Juárez, Chihuahua, México Integer Holdings Corporation A tiempo completo

    At Integer Holdings Corporation, we are committed to upholding the highest standards of quality in the medical device industry.Job Summary:We are seeking a highly skilled Quality Assurance Engineer to join our team. This individual will be responsible for ensuring compliance with established standards, client and/or medical devices industry requirements,...

  • Quality Assurance Specialist

    hace 3 horas

    Juárez, Chihuahua, México HARMAN International A tiempo completo

    Unlock Your Potential at HARMANHARMAN International, a leading technology company, is seeking an experienced Quality Assurance Specialist to join our team.About the RoleWe are looking for a highly skilled Quality Engineer who will lead internal and external quality initiatives, facilitate problem-solving activities, and ensure consistent quality...

  • Quality Assurance Specialist

    hace 4 semanas

    Juárez, Chihuahua, México Ambu A tiempo completo

    Job Summary:The Quality System Engineer will be responsible for ensuring compliance with quality standards and regulations in our manufacturing facility. This role involves maintaining quality systems, conducting root cause investigations, and leading quality projects with cross-functional teams.Key Responsibilities:Develop and implement quality systems to...

  • Quality Assurance Specialist

    hace 1 mes

    Juárez, Chihuahua, México LACROIX A tiempo completo

    Quality Assurance SpecialistAt LACROIX, we are seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services.Key Responsibilities:Represent customers in terms of quality within LACROIX.Contribute to the development of a climate of trust with...

  • Senior Quality Assurance Engineer

    hace 3 semanas

    Juárez, Chihuahua, México Johnson & Johnson A tiempo completo

    Supplier Quality Management StrategyAt Johnson & Johnson, we are committed to maintaining the highest standards of quality and compliance in our supply chain. As a Senior Supplier Quality Engineer, you will play a pivotal role in developing and implementing effective supplier quality management strategies, ensuring the delivery of high-quality products and...

  • Quality Assurance Specialist

    hace 1 semana

    Juárez, Chihuahua, México Brp A tiempo completo

    Company OverviewWe're a world leader in recreational vehicles and boats, creating innovative ways to move on snow, water, asphalt, dirt, and even in the air. Our company is rooted in a spirit of ingenuity and intense customer focus.Estimated Salary Range: $90,000 - $120,000 per yearJob DescriptionIn this role as Quality Assurance Specialist - Mechanical...

  • Quality Assurance Expert

    hace 7 días

    Juárez, Chihuahua, México Johnson And Johnson A tiempo completo

    Job SummaryWe are seeking a highly skilled Quality Assurance Expert to join our team in Juarez, Chihuahua. As a Senior Customer Quality Engineer, you will play a crucial role in supporting customer complaint investigation and analysis processes for the Ethicon Franchise.