12 часов назад
Supervisor, Quality Operations - Turno C (Medical Devices)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Supervisor, Quality Operations - Turno C (Medical Devices): Ensuring compliance with quality system regulations and manufacturing processes at the Haina facilities with an accent on GMP, FDA, ISO requirements, process validation, and nonconformance management. Focus on evaluating product and process changes, leading corrective and preventive actions, and delivering medium- and high-complexity quality improvement projects.
Location: Haina, San Cristóbal, Dominican Republic. Night shift: 11:00 p.m.–7:00 a.m., Monday through Friday.
Company
develops medical products and therapies focused on improving healthcare outcomes and saving and sustaining lives.
What you will do
- Ensure compliance with quality system regulations across quality and manufacturing processes.
- Participate in equipment and new subassembly process validation protocols.
- Evaluate customer complaints, nonconformances, exceptions, CAPA activities, and corrective actions.
- Own investigations and action items related to internal and external audits.
- Verify DHR documentation, specifications, local procedures, and final-product shipping dispositions.
- Lead quality improvement projects and collaborate with manufacturing, IT, process/product, and automation engineering teams.
Requirements
- Bachelor’s degree in science, engineering, or a related discipline.
- At least 3 years of experience in the medical device industry, preferably in quality.
- More than 1 year of previous supervisory experience.
- Knowledge of statistical applications and quality sampling techniques.
- Fully bilingual in English and Spanish.
- Availability for the 11:00 p.m.–7:00 a.m. Monday–Friday schedule.
Culture & Benefits
- Work in a patient-focused quality organization supporting medical products used worldwide.
- Collaborate with colleagues across a large multinational organization.
- Access opportunities to expand knowledge across different facets of the healthcare portfolio.
- Work in an environment emphasizing integrity, transparency, proactivity, collaboration, and results.
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