Senior Compliance Specialist

2 days ago

Baguio City, Cordillera, Philippines beBeeCompliance Full time ₱4,000,000 - ₱6,000,000

Job Overview

This role involves championing quality within our organization, ensuring overall compliance to standard operating procedures in line with our Quality Management System.


Key Responsibilities

  • Monitor and maintain our purpose-built Quality Management System, aligning it with ISO 13485 and ISO 9001 standards.
  • Develop audit programs and plans, performing internal audits and coordinating external audits.
  • Identify opportunities for improvement in company processes and systems and work with subject matter experts to drive implementation.
  • Manage CAPA related activities and identify relevant standards and regulations for product developments.
  • Facilitate risk management and user needs, requirements verification and validation activities throughout development.
  • Ensure quality for medical device development according to CE MDR, FDA, and TGA standards.
  • Select and evaluate suppliers, monitor quality agreements, and manage actions arising from goods inspection.

Requirements

  • 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 production/manufacturing processes and excellent verbal and written English communication skills.

Preferred Qualifications

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

Location

Manila


Job Type

  • Permanent Full-Time or Contract

Industry

  • Design Services

About Us

We provide comprehensive design services to leading companies.


Our team spans industrial and mechanical design, electronics, embedded, iOS, Android, Linux app, web servers, and more.


Workplace flexibility is provided by allowing staff to work from home. Permanent and contractor roles are available.

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