Quality Assurance Engineer II

hace 7 días

Alajuela, Alajuela, Costa Rica CooperSurgical A tiempo completo

Job Description
The Quality Engineer II is responsible for providing quality assurance knowledge and hands-on support for all aspects of production operations, quality control activities and transfer of new product launches and, ensuring that all site operations remain compliant with all FDA regulations, ISO standards, customer requirements, and internal policies and procedures. Under the direction of the site Quality Manager and or guidance from the Sr. Quality Engineer.

The Quality Engineer II will also be responsible for providing Quality representation and support in: the ongoing development, evaluation, and improvements of CooperSurgical quality programs and systems; quality assurance testing methodology, internal and external audits, vendor qualifications; training initiatives and programs; cross-functional process improvement activities; and any other business initiatives requiring Quality support.

Responsibilities
Essential Functions & Accountabilities:

  • Follow and ensure that all personnel comply with FDA regulations, 150 standards, customer requirements, and SOPs as defined by CooperSurgical policies and procedures.
  • Represent Quality in signing on Change Orders
  • Manage all Quality responsibilities for assigned manufacturing changes and transfer of new product launches,
  • Perform, Process recommend Improvements opportunities to processes, procedures and systema) to increase quality compliance.
  • Participate in validation activities, included but no limited to draft and/or review protocols and reports, qualify/validate production processes for installation qualifications (10), operational qualifications (OQ), and performance qualifications (PQ)
  • Ensure that all documentation is completed in a timely manner and follows established policies, practices, and procedures
  • Investigate customer complaints including root-cause analysis, develop and implement corrective action plans.
  • Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.
  • Effectively communicate and interact in a matrix environment.
  • Participate in CAPA activities as owners, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
  • Support all internal and external audits as subject matter experts
  • Supervise quality inspectors to ensure correct levels of service to production based on the plant priorities.
  • Train Quality and Manufacturing personnel on specifications, inspection and testing activities, new product audits, and environmental controls to ensure understanding and compliance, request training, training support, and/or re-trainings as needed.

Qualifications
Knowledge, Skills and Abilities:

  • Working knowledge of regulated environments (ISO 13485, 21 CFR 820, and/or other regulations).
  • Root Cause Analysis (CAPA/NCR) experience as owner.
  • Experience in planning Process Validation, IQ/OQ/PQ/MSA (software qualification a plus).
  • Knowledge of Statistical Analysis of data and related tools.
  • Advanced computer capabilities including Microsoft Office software.
  • Strong interpersonal, written, and oral communication skills both in English and Spanish.
  • Able to read and interpret blueprints and familiar with geometric dimension & tolerance (GD&T) procedures and requirements.

Experience:

  • Experience in medical device manufacturing.
  • 3+ years of work experience in Quality Engineering role or equivalent.

Education:

  • Bachelor's degree in engineering required.

  • Senior Manager, Quality Assurance Management

    hace 2 semanas

    Alajuela, Alajuela, Costa Rica CooperCompanies A tiempo completo

    CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated,...

  • Manufacturing Engineer II

    hace 1 semana

    Alajuela, Alajuela, Costa Rica Johnson & Johnson Innovative Medicine A tiempo completo

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...

  • Manufacturing Engineer II

    hace 1 semana

    Alajuela, Alajuela, Costa Rica Johnson & Johnson MedTech A tiempo completo

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...

  • Quality Eng II

    hace 2 semanas

    Alajuela, Alajuela, Costa Rica Boston Scientific A tiempo completo

    Recruiter: Francisco Munoz MunozDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that your...

  • Quality Assurance Finished Goods Release Inspector

    hace 1 semana

    Alajuela, Alajuela, Costa Rica Terumo Cardiovascular A tiempo completo

    ResponsibilitiesIn all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.Inspect and verify finished goods according to established procedures and quality standards.Review and confirm documentation for product release,...

  • Quality Systems Specialist II

    hace 1 día

    Alajuela, Alajuela, Costa Rica Cirtec Medical A tiempo completo

    DescriptionAbout us:For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery,...

  • Senior Manager, Quality Assurance Management

    hace 2 semanas

    Alajuela, Alajuela, Costa Rica CooperSurgical A tiempo completo

    Job DescriptionCooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values...

  • Senior Manager, Quality Assurance Management

    hace 1 semana

    Alajuela, Alajuela, Costa Rica CooperCompanies A tiempo completo

    DescriptionCooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values –...

  • Quality Engineer

    hace 5 días

    Alajuela, Alajuela, Costa Rica Freudenberg Medical A tiempo completo

    Working at Freudenberg: "We will wow your world" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 52,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.Freudenberg Medical is a...

  • Senior Quality Assurance Technician

    hace 2 semanas

    Alajuela, Alajuela, Costa Rica Confluent Medical Technologies A tiempo completo

    AtConfluent, we are committed to our values of teamwork, innovation, accountability, integrity, leadership, and customer focus, and we invest in a team who represents these values. Every member of our team plays a critical role in delivering life-saving medical devices through innovative materials science, engineering, and manufacturing. We are the medical...