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Quality Assurance Manager

Oxygen Development · Santiago de los Caballeros

New
Senior 🇬🇧 English
ISO 22716 CAPA Root Cause Analysis Quality Management Systems Audits

Job description

About the role

Oxygen Development is looking for an experienced Quality Manager to lead and oversee all quality operations at its Dominican Republic facility. The role ensures product quality, regulatory compliance and customer satisfaction across all finished goods made at the site, and suits someone with strong leadership experience in regulated manufacturing, including Quality Management Systems, audits, continuous improvement and regulatory standards.

Key responsibilities

  • Lead and manage the Quality Department, guiding, coaching and developing the team.
  • Ensure finished goods meet quality standards, customer requirements and regulatory requirements.
  • Maintain and improve the Quality Management System under ISO 22716 (Cosmetics GMP) and FDA OTC regulations.
  • Lead internal, customer, supplier, certification and regulatory audits and close findings on time.
  • Oversee investigations, root cause analysis, CAPA and non-conformance management.
  • Monitor quality KPIs, report performance and action plans to senior management, and partner with production and other teams to prevent customer complaints.
  • Ensure inspection, testing, documentation and final disposition of finished goods, and lead Quality Management Reviews.

Required profile

  • Bachelor's degree in Chemistry, Biology, Engineering or a related scientific field.
  • At least 5 years of progressive quality leadership experience in a regulated manufacturing environment.
  • Experience in cosmetics, OTC, pharmaceutical, medical device, food or similar regulated industries.
  • Experience managing Quality Management Systems, audits, investigations, CAPA and regulatory compliance.
  • Experience leading customer, certification, internal and regulatory audits; FDA-regulated experience preferred.
  • Strong leadership, analytical, problem-solving and decision-making skills; English proficiency desirable.

Required skills

  • Knowledge of ISO 22716 (Cosmetics GMP)
  • Quality Management Systems, CAPA and audit management

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Published 4 hours ago

Expires 1 month from now

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Oxygen Development

Santiago de los Caballeros