Quality Assurance Specialist

2 days ago

Calamba, Calabarzon, Philippines beBeeQuality Full time $75,000 - $135,000
Quality Management Professional

Key Responsibilities:

  • Lead and support quality management processes and teams.
  • Champion quality within the organization, ensuring alignment with corporate mission.
  • Monitor, maintain, and improve the quality management system in accordance with ISO 13485 and ISO 9001 standards.
  • Ensure compliance to standard operating procedures within the QMS framework.
  • Develop audit programs, perform internal audits, and coordinate external audits.
  • Identify opportunities for improvement in company processes and systems, collaborating with subject matter experts to drive implementation.
  • Manage CAPA-related activities, including processing and follow-up.
  • Stay updated on relevant standards and regulations, maintaining libraries of applicable standards across global markets.
  • Facilitate risk management in product development, adhering to best practices (ISO 14971, IEC 60812, ISO 31000).
  • Assure product user needs, requirements verification, and validation throughout development, ensuring traceability.
  • Oversee quality management for medical device development, adhering to regulations like CE MDR, FDA, and TGA, as well as standards such as ISO 13485, IEC 60601, and IEC 62304.
  • Coordinate calibration of test and measurement equipment.
  • Select and evaluate suppliers, monitor quality agreements, and manage actions resulting from goods inspection.
  • Develop and deliver induction and training on QMS processes and policies, promoting QMS regulatory requirements among staff.

Required Skills and Qualifications:

  • Rlevant qualification from a reputable educational institution.
  • Minimum 5 years' experience in quality management or a similar role.
  • In-depth knowledge of ISO 13485 and ISO 9001, along with regulatory requirements pertinent to product development.
  • Familiarity with various production/manufacturing processes.
  • Experience in communicating with and evaluating local and offshore suppliers.
  • Excellent verbal and written English communication skills.
  • Able to work independently and collaboratively as part of a team.

Benefits:

  • Workplace flexibility, allowing remote work arrangements.
  • Possibility of permanent or contractor roles.

About Us:

We provide comprehensive design services to leading companies across various industries. Our team offers a unique opportunity for creative professionals to continue developing their skills.

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