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Bayer

Quality Assurance Senior Associate

Ubicación del puesto

Heredia, Heredia, CR

Inocuidad, calidad y certificaciones

Descripción

La empresa publicó esta vacante en inglés

Quality Assurance Senior Associate

TASKS AND RESPONSIBILITIES

Perform the execution, documentation, and follow-up of technical complaint investigations for Essure, OEM devices, and other assigned products to support product quality assessments.
Manage and evaluate returned product samples, including visual, dimensional, and functional assessments, as applicable, and document results for complaint investigations and technical evaluations.
Review complaint information and support the assignment of initial risk classifications for Pharma Medical Devices in accordance with established procedures, escalating complex assessments to the QA Coordinator.
Perform complaint handling activities involving Country Quality Units (CQUs), third-party partners, and cross-functional stakeholders, including information collection, documentation, and action follow-up.
Monitor assigned complaint investigations and quality activities against established service level agreements (SLAs), follow up on pending actions, and escalate risks of delay or QMS deviation to the QA Coordinator or Home Lead.
Support Deviation, CAPA, Non-Conformance Report (NCR), and other quality event activities through data collection, investigation support, documentation preparation, action tracking, and maintenance of quality records.
Support post-market surveillance activities through data collection, complaint and quality data review, trend identification, preparation of metrics and periodic reports, and coordination of supporting documentation.
Perform Quality Management System activities, including document control, SOP updates, training assignments, MyLearning administration, and maintenance of compliant quality records and archives.
Perform supplier quality management activities through documentation preparation, follow-up of assigned actions, coordination with relevant stakeholders, and maintenance of applicable records.
Execute assigned product sustaining and operational quality activities, including NCR processing, inspection records, incoming inspection support, and product sample requests, in accordance with established procedures.
Support audits, inspections, process transitions, compliance activities, and continuous improvement initiatives by preparing evidence, tracking actions, and maintaining required documentation.
Maintain accurate data in applicable complaint and quality systems, prepare analyses and reports, and provide backup support during workload peaks or absences.
Collaborate with global and local stakeholders to support timely completion of quality activities and escalate potential product quality, compliance, safety, or operational risks to the QA Coordinator or appropriate responsible function.

WHO YOU ARE

Advanced or completed Engineering degree, or a comparable scientific or technical discipline.
2-4 years of experience in Complaint Handling, Quality Assurance, Medical Devices, Pharmaceuticals, GMP, or another regulated industry.
English and Spanish at least B2/C1, written and spoken - mandatory.
Quality mindset, customer focus, analytical thinking, attention to detail, and ability to support complex processes.
Effective communication and collaboration skills in an international and cross-functional context.
Computer literacy and ability to use the Office suite and applicable quality systems.

At Bayer we believe in diversity, equity and inclusion. We aim to create an environment in which everybody can feel authentic, respected and equally valued. Every day we strive to reflect our values through our unique capabilities, self-experiences, and aspirations. We intentionally seek diversity, to enable our people to bring their fullest potential out and encourage others to likewise do so. Our company wins when we leverage our capabilities to lead the cultural transformation in our business, positively impacting society.

Candidates who meet the requirements based on the job profile will be considered for employment regardless of physical disability, race, color, religion, sex, age, sexual orientation, gender identity and will not be at a disadvantage if unemployed.

Application Period: 8/19/2026 - 9/4/2026 Reference Code: 881481 Division: Enabling Functions Location: Costa Rica : Heredia : Heredia Functional Area: Quality Work Time: Full Time Employment Type: Regular Contact Us Address Heredia, Costa Rica