Director of Quality Assurance and Compliance

hace 1 semana


Tijuana, Baja California, México Optima Organizational Solutions A tiempo completo

Optima Organizational Solutions is a renowned leader in the medical devices industry, consistently recognized for its exceptional growth and innovative approach. We are currently seeking an experienced Director of Quality Assurance and Compliance to join our team at our manufacturing facility in Tijuana, Mexico.

About the Role:

  • To guarantee that all departments and suppliers adhere to US FDA regulations, manage and coordinate the implementation of quality system programs designed to ensure continuous production of products consistent with established standards and/or customer specifications.
  • Plan, implement, and direct the quality system program of the Tijuana manufacturing facility through failure investigation reporting, corrective action initiation, and tracking.

Key Responsibilities:

  • Administer the Tijuana manufacturing facility quality system, ensuring it meets requirements of Drug and Device Good Manufacturing Practices (cGMP) and ISO 13485 Quality System Standard.
  • Ensure quality system requirements are adequately defined, developed, and implemented.
  • Authorize non-conforming raw materials and components at incoming inspection.
  • Serve as the Quality System Management Representative for Tijuana facility during FDA, ISO, and customer assessments.

Requirements:

  • Bachelor's degree in Engineering or a physical science; Master's degree preferred.
  • Working knowledge of statistics and GMPs; computer literacy and familiarity with ISO standards.
  • Proven ability to manage a large department and handle multiple priorities simultaneously.

Estimated Salary Range: $80,000 - $110,000 per annum, depending on experience and qualifications.

Optima Organizational Solutions offers a competitive compensation package, comprehensive benefits, and opportunities for professional growth and development.



  • Tijuana, Baja California, México Sensata Technologies A tiempo completo

    The Sensata Technologies organization is dedicated to collaborating with talented individuals to drive innovation and excellence in quality assurance.Estimated salary range for this role is $120,000 - $180,000 per annum.Job Description:We are seeking an experienced Quality Assurance Director to lead our internal quality improvements and customer quality...


  • Tijuana, Baja California, México Fresenius Medical Care A tiempo completo

    About the Role: Fresenius Medical Care seeks a highly skilled Quality Assurance Director to oversee the development, implementation, and maintenance of our Quality System.Job Summary:Develop and maintain quality policies, procedures, and methodologies to ensure compliance with industry regulations and standards.Implement quality management systems, including...


  • Tijuana, Baja California, México Reckitt A tiempo completo

    About the RoleWe are seeking a seasoned professional to lead our EU Quality Assurance team as a Site Quality Manager. This pivotal role is based in the Netherlands and involves certifying and overseeing the supply of pharmaceutical products across Europe.Your ResponsibilitiesLead all Quality activities at the Reckitt NL site, ensuring batches are certified...

  • Quality Assurance Manager

    hace 2 semanas


    Tijuana, Baja California, México Harmac, Medical Products, Tijuana A tiempo completo

    Job DescriptionThe Quality Assurance Manager plays a crucial role in ensuring the quality of products and processes at Harmac, Medical Products, Tijuana.About Us:Harmac, Medical Products, is a leading manufacturer of medical devices. We are committed to delivering high-quality products that meet regulatory standards.Key Responsibilities:Product Reliability:...


  • 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...


  • Tijuana, Baja California, México Medtronic A tiempo completo

    As a key member of Medtronic’s quality assurance team, you will play a crucial role in ensuring the highest level of product quality and regulatory compliance.**Job Summary:**The Quality Assurance Specialist III will support post-market EU MDR remediation and implementation projects, focusing on delivering quality parts, materials, and services. This...


  • Tijuana, Baja California, México Tecma A tiempo completo

    Job OverviewTecma is seeking a highly motivated and experienced Quality Assurance Manager to oversee the quality management system and ensure the production and delivery of defect-free products.The successful candidate will direct and supervise quality personnel, communicate product testing needs with QA and production, and ensure that in-process and final...


  • Tijuana, Baja California, México Baxter A tiempo completo

    About UsBaxter 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...


  • 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'...


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

    **Job Summary:**We are seeking a highly skilled Senior Quality Assurance Engineer to join our team at North American Production Sharing. In this role, you will be responsible for ensuring compliance with quality standards and regulations in our production processes.**Key Responsibilities:Conduct comprehensive audits of processes, products, and systems to...


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

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Thermo Fisher Scientific. As a key member of our quality team, you will play a crucial role in ensuring the highest standards of quality and regulatory compliance in our medical device manufacturing operations.Job SummaryThe successful candidate will be responsible...


  • 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...


  • Tijuana, Baja California, México Ontex Mexico A tiempo completo

    OverviewIn Ontex Mexico, we are seeking a highly skilled and experienced Lead Quality Assurance Specialist to join our team. As a key member of our quality department, you will play a vital role in ensuring the highest standards of quality in our laboratory testing processes.About the JobWe offer a competitive salary range of $120,000 - $180,000 per annum,...


  • 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...


  • 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...


  • 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,...


  • Tijuana, Baja California, México CommScope A tiempo completo

    In today's fast-paced world, it is crucial to have a genuine connection with the work you do.We seek a dedicated Quality Assurance Inspector to join our team. Your primary responsibility will be to ensure product quality by conducting process audits and final product inspections in accordance with established AQL standards. You will also identify...


  • Tijuana, Baja California, México Avent, S. De R.L. De C.V. A tiempo completo

    Avent, S. De R.L. De C.V. seeks a highly skilled Sterility Assurance Specialist to join our team in Quality Assurance. As a key member of our quality team, you will be responsible for supporting the implementation of our Global Sterility Assurance Quality Operation program at our manufacturing sites.The successful candidate will have a B.S in Microbiology,...


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

    Role OverviewWe are seeking a highly motivated and detail-oriented Quality Assurance Specialist to support our quality management systems and processes.The ideal candidate will have excellent analytical skills, attention to detail, and strong communication skills to collaborate with cross-functional teams.Key ResponsibilitiesAssist in implementing and...


  • Tijuana, Baja California, México Medtronic A tiempo completo

    Medtronic OverviewAt Medtronic, we're driven by a singular purpose: to alleviate pain, restore health, and extend life. As a Quality Assurance Specialist for Supplier Partnerships, you'll be part of our team that helps bring this vision to life.About the RoleThis is an exciting opportunity to join our Supplier Quality Engineering team as a Quality Assurance...