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QMS Consultant
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We are seeking a Quality Management System (QMS) Consultant to support a QMS Remediation Plan for critical quality system improvement initiatives within a regulated medical device environment. This role is key to identifying compliance gaps, driving remediation activities, and strengthening the organization’s QMS to meet global regulatory standards. Lead and support quality system remediation projects, including gap assessments and corrective action plans Review, update, and enhance QMS documentation (procedures, work instructions, templates) Ensure compliance with regulatory standards such as: FDA (21 CFR Part 820) ISO 13485:2016 EU MDR 2017/745 MDSAP

Requisitos:
Requirements:
Bachelor’s degree in Engineering, Life Sciences, Quality, or related technical field 5+ years of QA experience in a regulated industry (medical device preferred) Strong knowledge of quality regulations and standards (FDA, ISO 13485, MDR, MDSAP) Experience with CAPA, audits, document control, and quality systems



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Empleos en Puerto RicoJobs in Puerto Rico
QRC GROUP LLC

Empleos en Puerto RicoJobs in Puerto Rico Ingenieros
Cidra PR 00600 Cidra
DescripciónDescription We are seeking a Quality Management System (QMS) Consultant to support a QMS Remediation Plan for critical quality system improvement initiatives within a regulated medical device environment. This role is key to identifying compliance gaps, driving remediation activities, and strengthening the organization’s QMS to meet global regulatory standards. Lead and support quality system remediation projects, including gap assessments and corrective action plans Review, update, and enhance QMS documentation (procedures, work instructions, templates) Ensure compliance with regulatory standards such as: FDA (21 CFR Part 820) ISO 13485:2016 EU MDR 2017/745 MDSAP Requisitos Requirements Bachelor’s degree in Engineering, Life Sciences, Quality, or related technical field 5+ years of QA experience in a regulated industry (medical device preferred) Strong knowledge of quality regulations and standards (FDA, ISO 13485, MDR, MDSAP) Experience with CAPA, audits, document control, and quality systems

Requiere Mucha Experiencia Requires Expert
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AVISO de ClasificadosOnline
Los patronos NO le piden dinero ni un depósito para trabajar, si lo piden es un negocio, inversión o Fraude.
NO envíe dinero para trabajar, tampoco ofrezca información personal, por teléfono o email.
 Evite el Fraude
ClasificadosOnline Warning
Employers DON'T ask for money or deposits for work, if they do is a bussiness, invertion or Fraud.
DON'T send money for work, neither offer personal information, by phone or email.
 Avoid the Fraud

Empleos en Puerto RicoJobs in Puerto Rico
QRC GROUP LLC

Empleos en Puerto RicoJobs in Puerto Rico Ingenieros
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