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Dätwyler

Quality Assurance Manager

Middletown, DEPosted 2 weeks ago
Full-timeonsitesenior

Job Description

  • Leads the Regulatory and External Customer Audits including preparation, execution and follow-up.
  • Maintains and continuously improves the site’s Quality Management System (QMS) in alignment with ISO 9001, ISO 15378, and other applicable regulations.
  • Oversees deviation management, CAPA, change control, complaints, and risk assessments, escalating critical issues to the Director of Quality.
  • Ensures timely and compliant batch record review and product release processes.
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