Senior Quality Manager

24 hours ago

Tarlac City, Central Luzon, Philippines beBeeQuality Full time ₱2,000,000 - ₱2,500,000
Quality Champion

We are seeking an exceptional Quality Champion to champion quality within our organization.

  • Main Responsibilities:
  • Champion quality across the organization, ensuring overall compliance to standard operating procedures in line with the Quality Management System (QMS).
  • Maintain and improve the purpose-built QMS in accordance with ISO 13485 and ISO 9001 standards.
  • Develop audit programs and plans, perform internal audits, and coordinate external audits.
  • Identify opportunities for improvement in company processes and systems, work with subject matter experts to drive implementation.
  • Manage CAPA related activities.
  • Advise on relevant standards and regulations for product developments, maintain up-to-date libraries of applicable standards and regulations across global markets.
  • Facilitate company and product development risk management in accordance with best practices.
  • Facilitate identification and records of product user needs, requirements verification and validation activities, and traceability throughout development.
  • Manage quality for medical device development according to regulation and standards.
  • Select and evaluate suppliers, monitor quality agreements, and manage actions arising from goods inspection.
  • Develop and conduct induction and training on QMS processes and policies, promote QMS regulatory requirements to all staff.
Requirements
  • A relevant qualification from a reputable education organization.
  • At least 5 years' experience in quality management or a similar role.
  • In-depth knowledge of ISO 13485 and ISO 9001, as well as regulatory requirements pertaining to product development.
  • Understanding of various production/manufacturing processes.
  • Experience in communicating with and evaluating local and offshore suppliers.
  • Excellent verbal and written English communication skills.
  • Ability to work independently and as part of a team.

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