Associate Manager, Quality Assurance NOLA
Associate Manager, Quality Assurance NOLA
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Job Description
What you will do:
Executes Quality Assurance / PMS (Post-Market Surveillance) activities in line with procedures and country-specific responsibilities.
Collects organizes and maintains RAQA (Regulatory Affairs & Quality Assurance) intelligence at local regional and global levels.
Identifies and implements new regulatory procedures SOPs (Standard Operating Procedures) and continuous improvement opportunities.
Acts as Quality Assurance Leader defining KPIs (Key Performance Indicators) reporting performance risks and issues to local leadership.
Leads audits (Third Party Competent Authority Notified Body) within the local organization.
Supports Latin America/Country Quality Assurance teams talent development and integration of new acquisitions.
Represents Stryker as Quality Assurance subject matter expert in local industry associations and advocacy activities.
Ensures collaboration with manufacturing and design divisions to support local Quality Assurance and commercial needs.
What you will need:
Required:
Bachelors degree in a relevant field (Pharmaceutical Chemistry Engineering Pharmacy or related).
Minimum of 3 years of experience in Quality Assurance.
Strong expertise in Quality Management Systems.
Bilingual: Spanish and English.
Preferred:
Advanced Degree.
RAC (Regulatory Affairs Certification).
Expertise in ISO 13485 standards.
Experience in Medical Devices.
Required Experience:
Manager
Employment Type
Full-Time
