Quality Assurance Specialist

hace 3 semanas

Tijuana, Baja California, México Baxter A tiempo completo

About Us

Baxter is a leading medical products company that has been making a positive impact on people's lives for over 85 years. Our mission is to save and sustain lives, and we're committed to delivering innovative solutions that improve healthcare outcomes.

Our team is passionate about creating a workplace where our employees feel happy, successful, and inspired. If you're looking for a challenging and rewarding career opportunity, we encourage you to explore our current openings.

About the Role

We are seeking a Quality Assurance Specialist to join our team in [Location]. As a key member of our quality assurance department, you will be responsible for ensuring compliance with regulatory requirements, developing and implementing quality plans, and analyzing trends to identify areas for continuous improvement.

Responsibilities

  1. Oversee compliance with regulatory requirements of countries to which the product is exported, applicable international standards, and corporate requirements.
  2. Prepare quality records, including regulatory letters, product characteristics, and required submissions to regulatory entities.
  3. Develop and coordinate the Annual Internal Audit Schedule, ensuring planning, execution, root cause assessment, and CAPAs through TW9 and TW8 tools.
  4. Analyze responses to audit reports and effectiveness of preventive actions.
  5. Support training programs by training auditors and promoting understanding of regulatory standards, including ISO 13485, CFR 21-Part 820, and other applicable GxP regulations.
  6. Coordinate preparation activities (Readiness Plan) and follow up for interactions with regulatory agencies, external audits, inspections, and global internal audits, maintaining effective communication with auditing entities (BSI, TUV, and applicable MOH).
  7. Perform compliance analysis and develop action plans for non-compliance risks detected during internal assessments, keeping the management team aware of any non-compliance risks.
  8. Administer the Global Observations Program (GOCs).
  9. Develop and follow up on the Quality Plan for the subsidiary, derived from regulatory compliance, GOCs, and benchmarking.
  10. Analyze trends and identify areas for continuous improvement related to regulatory compliance, simplification, and savings, manage and develop projects with this focus.
  11. Establish a GEMBAS program to identify opportunities for improvement and promote understanding of GxP.
  12. Support quality system compliance through participation in investigations, ensuring activities related to NCR/CAPA follow-up are properly executed, completed, and documented.
  13. Foster a culture of compliance with ethical standards and practices in the organization.
  14. Support programs and initiatives related to the Code of Conduct, Cultural Levers, and continuous improvement programs.

What We Offer

We offer a competitive salary of $**$120,000 - $150,000 per year**, depending on experience, as well as a comprehensive benefits package, including health insurance, retirement plan, and paid time off. If you're a motivated and detail-oriented individual who is passionate about quality assurance, we encourage you to apply for this exciting opportunity.

How to Apply

To learn more about this role and how to apply, please visit our website at https://www.baxter.com/careers.

  • Quality Assurance Specialist

    hace 3 semanas

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

    North American Production Sharing seeks a Quality Assurance Specialist to ensure product quality meets specifications and supports customer needs.About the RoleWe are looking for an experienced Quality Assurance Specialist to join our team. The ideal candidate will have a strong background in quality assurance and experience working with multidisciplinary...

  • Quality Assurance Specialist

    hace 4 semanas

    Tijuana, Baja California, México Qima Hong Kong A tiempo completo

    Quality Assurance SpecialistAt Qima Hong Kong, we strive to deliver smart solutions that ensure the quality of our clients' products. As a Quality Assurance Specialist, you will play a crucial role in our mission to help brands, retailers, manufacturers, and growers achieve quality excellence.Key Responsibilities:• Conduct on-site quality inspections of...

  • Quality Assurance Specialist

    hace 3 semanas

    Tijuana, Baja California, México Eaton A tiempo completo

    Eaton's AER FED Fluid Electrical Distribution division is currently seeking a skilled Quality Assurance Specialist to join their team.**Job Overview**We are committed to ensuring the highest quality standards in our products and processes. As a Quality Assurance Specialist, you will play a crucial role in executing our Strategic Quality Plan and ensuring...

  • Quality Assurance Specialist

    hace 4 semanas

    Tijuana, Baja California, México Commscope A tiempo completo

    Job SummaryWe are seeking a Quality Assurance Specialist to join our team at CommScope. In this role, you will be responsible for ensuring the quality of our products and services.About CommScopeCommScope is a leading provider of communications infrastructure solutions. We believe that connectivity empowers how we live, work, and learn. Our employees push...

  • Senior Quality Assurance Specialist

    hace 2 semanas

    Tijuana, Baja California, México CommScope A tiempo completo

    About UsAt CommScope, we believe in delivering connectivity that empowers how we live, work, and learn. Our employees push the boundaries of communications technology, enabling game-changing discoveries like 5G, the Internet of Things, and gigabit speeds for everyone, everywhere.Our OpportunityWe are seeking a highly skilled Senior Quality Assurance...

  • Senior Quality Assurance Specialist

    hace 2 semanas

    Tijuana, Baja California, México Sensata Technologies A tiempo completo

    Job SummaryWe are seeking a Senior Quality Assurance Specialist to join our team at Sensata Technologies.

  • Quality Assurance Specialist I

    hace 3 semanas

    Tijuana, Baja California, México NEO Tech A tiempo completo

    Job DescriptionWe are seeking a highly skilled Quality Assurance Specialist I to join our team at NEO Tech. This role is responsible for ensuring the highest quality standards in our manufacturing process.

  • Quality Assurance Specialist

    hace 4 semanas

    Tijuana, Baja California, México Safran Electronics & Defense A tiempo completo

    Job SummaryOur team at Safran Electronics & Defense is seeking a Quality Assurance Specialist to ensure the quality of our products and processes align with internal and regulatory standards. Key ResponsibilitiesDevelop and implement quality assurance strategies to maintain a healthy Quality Management System.Utilize process improvement tools such as Lean...

  • Quality Assurance Specialist

    hace 3 semanas

    Tijuana, Baja California, México Thermo Fisher Scientific A tiempo completo

    Job Description:At Thermo Fisher Scientific, we are seeking a highly skilled Quality Assurance Specialist to join our team in Tijuana. This role offers an exciting opportunity to be part of a company that prioritizes innovation and continuous improvement in a collaborative setting.We are looking for a dedicated professional with proven experience in quality...

  • Quality Assurance Specialist

    hace 2 meses

    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...

  • Manufacturing Quality Assurance Specialist

    hace 3 semanas

    Tijuana, Baja California, México Medtronic A tiempo completo

    About the RoleWe are seeking a talented Manufacturing Quality Assurance Specialist to join our team at Medtronic. In this role, you will be responsible for developing and maintaining quality standards and protocols for processing materials into partially finished or finished products.

  • Quality Assurance Specialist

    hace 2 semanas

    Tijuana, Baja California, México Commscope A tiempo completo

    Job OverviewWe are seeking a highly skilled Quality Assurance Specialist to join our team. This role plays a vital part in ensuring the quality of our products by conducting process and product audits, with a focus on established AQL standards.About CommScopeAt CommScope, we believe that genuine connections with our work are essential in today's 'always on'...

  • Product Quality Assurance Specialist

    hace 3 semanas

    Tijuana, Baja California, México Eaton A tiempo completo

    We are committed to excellence in delivering high-quality products to our customers. As a Product Quality Assurance Specialist at Eaton, you will play a crucial role in ensuring that our Fluid Electrical Distribution division meets the highest standards of quality.About the JobThis position is responsible for executing the defined Strategic Quality Plan in...

  • Senior Quality Assurance Specialist

    hace 3 semanas

    Tijuana, Baja California, México Medtronic A tiempo completo

    Careers that Make a DifferenceA Day in the Life of a Quality EngineerWe're seeking an experienced Quality Assurance Specialist to join our team. In this role, you will be responsible for developing and implementing quality standards and protocols for processing materials into partially finished or finished products.Main Responsibilities:Collaborate with...

  • Quality Assurance Specialist

    hace 2 semanas

    Tijuana, Baja California, México Ericsson A tiempo completo

    At Ericsson, we are seeking a Quality Assurance Specialist to join our team in implementing and maintaining our Environmental Management Systems (EMS) across various locations. This is an exciting opportunity for a detail-oriented individual with experience in quality assurance and environmental management to contribute to our goal of reducing our ecological...

  • Quality Assurance Specialist

    hace 4 semanas

    Tijuana, Baja California, México Medtronic A tiempo completo

    Job Summary: We are seeking a highly skilled Quality Assurance Specialist to join our team at Medtronic. This role is responsible for ensuring that suppliers deliver high-quality parts, materials, and services.About the Role: As a Quality Assurance Specialist, you will be responsible for qualifying suppliers according to company standards, monitoring parts...

  • Quality Assurance Specialist

    hace 2 semanas

    Tijuana, Baja California, México Eaton A tiempo completo

    About the RoleWe are seeking an experienced Quality Assurance Specialist to join our team at Eaton in Tijuana, Mexico. This is a great opportunity for someone with a passion for quality and process improvement to work closely with plant leadership to drive strategic initiatives.Estimated Salary: $60,000 - $80,000 per year, depending on experience.Job...

  • Quality Assurance Specialist

    hace 3 semanas

    Tijuana, Baja California, México Resideo A tiempo completo

    At Resideo, we are seeking a talented Quality Assurance Specialist to join our team at our manufacturing site in Tijuana.Estimated Salary:$85,000 - $110,000 per yearJob Description:Key Responsibilities:Apply expertise and knowledge to improve quality output and drive process initiatives that ensure compliance with customer requirements, regulatory agencies,...

  • Quality Assurance Specialist

    hace 2 semanas

    Tijuana, Baja California, México Sensata Technologies, Inc. A tiempo completo

    About the Role: We are seeking a highly skilled Quality Assurance Specialist to join our team at Sensata Technologies, Inc. As a Quality Assurance Specialist, you will be responsible for supporting strategic customer accounts with direct customer interface to drive quality improvement. You will respond to customer issues with crisp communication and provide...

  • Quality Assurance Process Specialist

    hace 2 semanas

    Tijuana, Baja California, México Enovis A tiempo completo

    Job SummaryWe are seeking a skilled Quality Assurance Process Specialist to join our team at Enovis. This role is responsible for designing, implementing and maintaining quality assurance protocols and methods for processing materials into partially finished or finished products.About the RoleThis position is accountable for planning, implementing and...