Supervisor, Quality Operations - Turno C

baxter · Haina

New

Mid 🇬🇧 English

GMP FDA ISO statistical applications

Job description

About the role

The Quality Supervisor ensures compliance with quality system regulations and supports process control at the Haina facility, participating in protocols, non‑conformance evaluations, and product improvements.

Key responsibilities

Maintain compliance with GMP, FDA, ISO and other regulatory requirements.
Support design, development, and enhancement of new product processes and technologies.
Evaluate customer complaints and implement corrective and preventive actions.
Lead investigations for internal and external audits, NCRs, CAPA, and quality improvement projects.
Develop and evaluate quality sampling plans and verify DHR documentation.

Required profile

BS degree in science, engineering or related discipline.
At least 3 years of experience in the medical device industry, with 1+ year in a supervisory role.
Fully bilingual in English and Spanish.
Availability to work the night shift (11:00 pm‑7:00 am, Monday‑Friday).

Required skills

Knowledge of GMP, FDA and ISO regulations.
Statistical applications and quality sampling plan techniques.

Questions fréquentes

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Source : ats:workday

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Published 13 hours ago

Expires 1 month from now

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baxter

Haina

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