Quality Assurance Specialist

hace 1 semana


Alajuela, Alajuela, Costa Rica Abbott Laboratories A tiempo completo

About Abbott Laboratories

We are a global healthcare leader, creating breakthrough science to improve people's health. Our vision is to be the best healthcare company in the world.

Why Choose Abbott?

We offer a dynamic work environment with opportunities for growth and development. You will have access to:

- A company recognized as a great place to work in dozens of countries around the world.
- A company that is recognized as one of the most admired companies in the world by Fortune.
- A company that values diversity and inclusion.

The Opportunity

This position works out of our Alajuela location. As a Quality Engineer I, you'll work closely with Manufacturing and Engineering on sustaining activities to ensure compliance with quality system requirements and achievement of Key Performance Indicators (KPIs). You will support process/product validation activities and work with Research and Development and Regulatory Affairs personnel to obtain support on sustaining activities to assure compliance with product and regulatory requirements.

Your Responsibilities

- Verify company adherence to established quality systems and GMP/ISO standards.
- Assist in completion of risk management and risk analysis including FMEA.
- Support technical and statistical investigations concerning optimization and compliance to specification.
- Assist in measuring process capability, process controls, and process validation efforts.
- Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities.
- Conduct NCMR Investigations, Calibration Out of Tolerance (OOT) Investigations and Complaint Investigations (MA) related to manufacturing Process.
- Complete and Document Monthly Quality Data Review.
- Lead Build At Risk (BAR) Authorizations & Closures.
- Completion and approval of document Change Requests, assuring accuracy, adequacy, and compliance to Quality System and product requirements.
- Create and maintain Quality Plans and Reports, typically with mentorship from higher level engineering.
- Execute IQ, OQ, PQ, and/or PPQ Qualifications and Inspection and Test Method Qualifications, typically with mentorship from higher level engineering.
- Conduct Advanced Statistical Data Analyses using Minitab, typically with mentorship from higher level engineering.
- Maintenance/update to Master Validation Plans and Reports.
- Support Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.).
- Collaborate with cross-functional teams to resolve quality issues and improve processes.

Requirements

- Bachelor's degree in STEM field (Science, Technology, Engineering, and Math).
- 0-3 years of experience in quality assurance or related field.
- Knowledge of statistical and data analysis techniques.
- Familiarity with process improvement tools such as Root Cause Analysis, Fishbone Diagram, Is/Is Not, Six Sigma, and Quality Tools.
- Understanding of FDA, GMP, and ISO 13485 regulations.
- Intermediate commands of English language.
- Ability to work fully on-site.

Preferred Qualifications

- Prior experience in medical device industry.
- Previous quality engineering experience.
- Experience with SAP ERP system.
- Knowledge on product and process qualification and validation.

We offer a competitive salary range of $60,000 - $80,000 per year, based on your qualifications and experience. This estimate may vary depending on factors such as location and performance.



  • 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...


  • 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...


  • Alajuela, Alajuela, Costa Rica Abbott Laboratories A tiempo completo

    At Abbott, you can do meaningful work that contributes to the advancement of human health. Our commitment to innovation and quality drives us to create life-changing technologies that make a difference in people's lives.We are currently seeking a Senior Quality Assurance Specialist to join our Electrophysiology Division in Alajuela, Costa Rica. As a member...


  • 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...


  • Alajuela, Alajuela, Costa Rica Abbott Laboratories A tiempo completo

    We are seeking a skilled Technical Quality Assurance Specialist to join our team at Abbott Laboratories.About the RoleThis is a fantastic opportunity for a dedicated and detail-oriented professional to apply their knowledge and skills in quality assurance to drive excellence in our products.The successful candidate will be responsible for ensuring that all...


  • 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...


  • 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...


  • 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...


  • 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...


  • 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...


  • 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...


  • 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...


  • Alajuela, Alajuela, Costa Rica Philips A tiempo completo

    Company Overview:At Philips, we're a health technology company built on the belief that every human matters. Our mission is to provide quality healthcare to all.Salary and Benefits:The estimated salary for this position is $120,000 per year. As a key member of our team, you'll enjoy a comprehensive benefits package, including health insurance, retirement...


  • 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...


  • 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...


  • 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...


  • Alajuela, Alajuela, Costa Rica Jll A tiempo completo

    We are seeking a highly skilled Quality Assurance Specialist to join our Global Operational Excellence team at JLL. This is an exciting opportunity to make a meaningful impact on the company's quality control procedures and ensure smooth workflow.The ideal candidate will have a minimum of three years of experience with an organization's quality control...


  • Alajuela, Alajuela, Costa Rica Abbott Laboratories A tiempo completo

    About Abbott LaboratoriesAbbott Laboratories is a leading global healthcare company, dedicated to developing innovative medical products that improve people's lives. As a Quality Assurance Specialist, you will be part of a team that strives for excellence in quality and safety.The OpportunityThis position is based in our Costa Rica location and is...


  • Alajuela, Alajuela, Costa Rica Cardinal Health A tiempo completo

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Cardinal Health. In this role, you will be responsible for ensuring that our suppliers meet the highest standards of quality and reliability.Job SummaryThe Supplier Management Professional will work closely with our internal stakeholders to develop and implement...


  • Alajuela, Alajuela, Costa Rica Nevro A tiempo completo

    About the RoleNevro is seeking a Quality Assurance Specialist to join our team. This is an exciting opportunity to work with a leading medical device company and contribute to the development of innovative implantable medical devices.