Quality Assurance Specialist

hace 2 meses

Alajuela, Alajuela, Costa Rica Nevro A tiempo completo
Job Summary

The Quality Engineer is responsible for ensuring compliance in product and process development, validations, and process optimization for Class III medical devices. This is a hands-on role where the Quality Engineer will apply intensive knowledge of engineering and quality principles and practices for implantable medical devices and accessories.

Key Responsibilities
  • Establish and maintain receiving inspection procedures to support product and receiving inspections.
  • Write, review, and/or approve validation plans, protocols, and reports in accordance with applicable regulatory requirements and Nevro SOPs.
  • Analyze data and perform statistical analysis to ensure validation meets predefined acceptance criteria.
  • Collaborate with cross-functional teams to implement and align Quality Control inspection plans, requirements, and methodologies.
  • Provide guidance to manufacturing processes and personnel.
  • Work with cross-functional teams to implement comprehensive preventative maintenance work instructions and revalidation requirements.
  • Review and disposition Non-conformance reports and perform Root Cause analysis to determine corrective and preventive action activities.
  • Ensure appropriate process outputs and process controls are translated into Quality Control Plans, Work Instructions, and Device Records.
  • Evaluate risk, manage risk assessment activities, and create associated documentation.
  • Investigate and implement solutions to internal and external audit findings.
  • Lead Supplier management and Supplier Quality activities for local suppliers.
  • Collaborate with Suppliers to identify and define corrective actions and follow-up to ensure completeness and effectiveness of Supplier improvements to meet Nevro and applicable regulatory requirements.
  • Participate in audits (internal & external) and regulatory agency inspections.
  • Responsible for review/release of Batch Record(s) and review of other documentation from medical device manufacturing and packaging suppliers, ensuring all activities comply with quality requirements and Nevro procedures.
  • Responsible for performing Quality assessment of changes to manufacturing processes, materials, and procedures and ensuring applicable and appropriate documentation are generated.
  • Supervise Quality Inspectors and Technicians.
Requirements
  • Bachelor's degree in a relevant technical discipline required; advanced degree preferred.
  • Equivalent years of experience may be substituted for education requirement.
  • No fewer than four (4) years of directly related experience, with at least two (2) of those years in a Class II or III medical device environment, preferably in implantable devices.
  • Experience in the medical device industry and with extensive knowledge performing their function within the Food & Drug Administration (FDA), Quality System Regulations (QSRs), International Organization of Standardization (ISO), and Implantable Medical Device Directive.
  • 2+ years in Quality Assurance and/or Quality Systems function in the Medical Device industry.
  • Prior experience working with US companies a plus.
  • Knowledgeable with the ISO Requirements and QSR requirements.
  • Strong communication skills, both verbal and written, and the ability to effectively communicate throughout all levels of the organization.
  • Experience in managing quality system activities not limited to product audits, CAPA, and supplier corrective action request (SCAR).
  • Cross-functional collaboration with Quality, Regulatory, Engineering, Manufacturing/Production, Supply Chain, etc.
  • Strong working knowledge of quality system processes, validations, and audits (internal and external).
  • Strong problem-solving, organizational, analytical, and critical thinking skills.
  • Root cause analysis and implementation of corrective action for process-related concerns.
  • Knowledge on sterilization and biocompatibility is a plus.
  • Experience performing Quality inspection to ensure products and processes comply with the relevant requirements of the QMS.
  • Analyze failure, corrective, and preventive action to respond to internal/external customer complaints.
  • Ability to travel on a needed basis.
  • Ability to work closely with peers in Redwood City, CA.
  • Ability to multi-task, work under pressure, and meet deadlines required.
  • Ability to effectively present information and respond to questions from groups of managers, clients, and customers.
  • Ability to communicate fluently in Spanish, both verbal and written.
  • Ability to communicate fluently in English, both verbal and written.

  • Quality Assurance Specialist

    hace 2 semanas

    Alajuela, Alajuela, Costa Rica Cardinal Health A tiempo completo

    **Quality Assurance Role at Cardinal Health**At Cardinal Health, we are seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring that our products meet the highest standards of quality.**Key Responsibilities:**Perform product inspections and analysis to ensure compliance with regulatory...

  • Quality Assurance Specialist

    hace 2 semanas

    Alajuela, Alajuela, Costa Rica Philips A tiempo completo

    **Job Title**: Quality assurance specialist**Job Role**: Ensure the quality of our products by identifying and mitigating potential issues.**Key Responsibilities**:- Collaborate with cross-functional teams to develop and implement quality assurance processes.- Conduct thorough risk assessments to identify potential quality issues.- Develop and maintain...

  • Quality Assurance Specialist

    hace 2 meses

    Alajuela, Alajuela, Costa Rica MicroVention A tiempo completo

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at MicroVention. As a key member of our supplier quality team, you will be responsible for ensuring that our suppliers meet the highest quality standards.Key ResponsibilitiesSupplier Quality Audits: Conduct regular audits of our suppliers to ensure compliance with our...

  • Senior Quality Assurance Engineer

    hace 1 semana

    Alajuela, Alajuela, Costa Rica CooperCompanies A tiempo completo

    The Quality Assurance Specialist II is responsible for ensuring quality compliance in all aspects of production operations. This role involves providing quality assurance knowledge and hands-on support, ensuring that all site operations remain compliant with FDA regulations, ISO standards, customer requirements, and internal policies and procedures.Key...

  • Quality Assurance Specialist

    hace 2 semanas

    Alajuela, Alajuela, Costa Rica Hologic, Inc. A tiempo completo

    Job SummaryAs a Quality Assurance Specialist at Hologic, Inc., you will play a key role in ensuring the quality of our products and processes. This position requires a strong background in engineering and a minimum of 2 years of experience in a technical field professional role.Key Responsibilities• Plan, coordinate, and optimize process improvement...

  • Quality Assurance Specialist

    hace 2 semanas

    Alajuela, Alajuela, Costa Rica Freudenberg Medical Srl. A tiempo completo

    At Freudenberg Medical, we are committed to delivering high-quality medical devices that save and improve lives. As a Quality Assurance Specialist, you will play a critical role in ensuring our products meet the highest standards of quality, safety, and efficacy.**Responsibilities:**Develop and implement quality systems and processes to ensure compliance...

  • Quality Assurance Specialist

    hace 2 semanas

    Alajuela, Alajuela, Costa Rica Cardinal Health A tiempo completo

    **Job Summary**We are seeking a skilled Quality Assurance Specialist to join our team at Cardinal Health. In this role, you will participate in quality engineering functions related to validation and supplier quality for our project Craft. You will work closely with our Engineering team to ensure quality considerations are adequately covered in validations...

  • Quality Assurance Specialist

    hace 5 días

    Alajuela, Alajuela, Costa Rica Abbott A tiempo completo

    Job SummaryThe Quality Assurance Specialist will work out of our Alajuela, Coyol location in the Vascular division, responsible for ensuring the quality of innovative, minimally invasive, and cost-effective products for the treatment of vascular disease.Key ResponsibilitiesApply quality principles, analyze quality records, and prepare reports to recommend...

  • Global Quality Assurance Specialist

    hace 15 horas

    Alajuela, Alajuela, Costa Rica Abbott A tiempo completo

    Abbott's Structural Heart Division is seeking a highly skilled Global Quality Assurance Specialist to join our team in Costa Rica – Alajuela. As a key member of our Supply Chain organization, you will play a critical role in ensuring the quality and reliability of our products.The successful candidate will be responsible for managing supplier...

  • Supplier Quality Assurance Specialist

    hace 3 semanas

    Alajuela, Alajuela, Costa Rica Cardinal Health A tiempo completo

    Job SummaryWe are seeking a skilled Supplier Quality Assurance Specialist to join our team at Cardinal Health. This role is responsible for ensuring the quality of external suppliers and their products, in accordance with regulatory standards and company policies.Key ResponsibilitiesEvaluate and qualify external suppliers to ensure they meet quality and...

  • Quality Assurance Specialist

    hace 2 semanas

    Alajuela, Alajuela, Costa Rica Jll A tiempo completo

    JLL supports the Whole You, personally and professionally.As a Quality Assurance Specialist, you will be a key member of the Global Operational Excellence team, helping to continuously improve and execute our Quality Program.**Responsibilities:**Support management and leadership for the design, development and implementation of programs to create a risk...

  • Quality Assurance Specialist

    hace 2 semanas

    Alajuela, Alajuela, Costa Rica Riverpoint Medical A tiempo completo

    Riverpoint Medical is seeking a Quality Assurance Specialist to drive proactive improvements to quality systems and processes. As a key member of our team, you will collaborate with Operations and Engineering to ensure product quality and conformance to specifications, manage and resolve non-conformities, lead process and equipment validations, resolve...

  • Quality Assurance Specialist

    hace 1 semana

    Alajuela, Alajuela, Costa Rica CooperCompanies A tiempo completo

    Job Title: Supplier Quality Assurance ManagerJob Summary: We are seeking a highly skilled Supplier Quality Assurance Manager to join our team at CooperCompanies. As a key member of our quality team, you will be responsible for ensuring that our suppliers meet our quality and regulatory requirements. Your expertise will help us to maintain our high standards...

  • Quality Assurance Specialist

    hace 2 semanas

    Alajuela, Alajuela, Costa Rica Abbott Laboratories A tiempo completo

    MAIN PURPOSE OF ROLEAn engineering professional who applies scientific knowledge, engineering knowledge, mathematics, and ingenuity to complete assignments related to a specific technical field or discipline.At Abbott Laboratories, we are seeking a Quality Assurance Specialist to provide Quality support to manufacturing, ensuring delivery of the highest...

  • Quality Assurance Specialist III

    hace 2 semanas

    Alajuela, Alajuela, Costa Rica Abbott Laboratories A tiempo completo

    About AbbottAbbott is a global healthcare leader, creating breakthrough science to improve people's lives.Working at AbbottWe offer a collaborative environment where you can grow and learn, care for yourself and your family, be your true self, and live a full life. Some of the benefits include:Career development opportunities with an international...

  • Quality Assurance Supervisor

    hace 3 semanas

    Alajuela, Alajuela, Costa Rica Philips A tiempo completo

    Job Title: Quality Assurance SupervisorPhilips is seeking a Quality Assurance Supervisor to join our team. As a Quality Assurance Supervisor, you will be responsible for ensuring the quality of our products and processes.Key Responsibilities:Develop and implement quality control procedures to ensure compliance with regulatory requirements.Lead a team of...

  • Medical Device Quality Assurance Specialist

    hace 7 días

    Alajuela, Alajuela, Costa Rica Nevro A tiempo completo

    Job SummaryThe Quality Assurance Specialist will ensure compliance with product and process development, validations and process optimization, line support, acceptance sampling, and continuous improvement for Class III medical devices. This role requires hands-on expertise, self-directed knowledge of engineering and quality principles, and practices for...

  • Quality Assurance Specialist

    hace 2 semanas

    Alajuela, Alajuela, Costa Rica MicroVention A tiempo completo

    Job Summary:The Quality Technician II provides critical support to the quality reliability team by ensuring finished products meet established quality standards and worldwide regulatory requirements. This position requires the ability to handle a diverse set of projects and tasks.Key Responsibilities:Comply with applicable laws and regulations, adhere to...

  • Quality Assurance Specialist

    hace 3 semanas

    Alajuela, Alajuela, Costa Rica CooperCompanies A tiempo completo

    Job Title: Quality Engineer IIThe Quality Engineer II is a key member of the CooperSurgical team, responsible for ensuring the highest quality standards in our manufacturing operations. This role requires a strong understanding of quality assurance principles, regulatory requirements, and industry best practices.Key Responsibilities:Develop and implement...

  • Quality Assurance Specialist

    hace 2 semanas

    Alajuela, Alajuela, Costa Rica Philips A tiempo completo

    Job Title: Supplier Quality EngineerSupplier Quality EngineerAs a key member of the Philips team, you will be responsible for the development, procurement, and continuous improvement of manufacturing materials, components, software, and sub-assemblies. Your primary goal will be to ensure that all supplied parts meet specifications and control...