Quality Excellence Leader

2 days ago

Paranaque City, Calabarzon, Philippines beBeeQuality Full time $700,000 - $1,000,000
Job Opportunity

As a Quality Champion, you will drive quality excellence within the organization. Your role will involve monitoring and maintaining our Quality Management System in accordance with ISO 13485 and ISO 9001 standards.

Key Responsibilities:

  • Leading quality initiatives to fulfill corporate objectives.
  • Maintaining and improving our purpose-built Quality Management System.
  • Ensuring overall compliance to standard operating procedures.
  • Developing audit programs and plans, performing internal audits and coordinating external audits.
  • Identifying opportunities for improvement and driving implementation.
  • Managing CAPA related activities.
  • Advising on relevant standards and regulations for product developments.
  • Facilitating risk management and quality control throughout development.
  • Managing quality for medical device development according to regulations and standards.
  • Managing test equipment calibration.
  • Selecting and evaluating suppliers, monitoring quality agreements, and managing actions arising from goods inspection.
  • Developing and conducting training on QMS processes and policies.

Requirements:

  • A relevant qualification from a reputable education institution.
  • 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.
  • 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.

Bonus Points:

  • ISO 17955 Lead Auditor certification.
  • Quality management experience in product design and development.

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