Senior Quality Assurance Specialist

1 day ago

Batangas, Calabarzon, Philippines beBeeQuality Full time ₱1,000,000 - ₱1,200,000
Quality Assurance Role

We are seeking a highly skilled and experienced Quality Assurance professional to champion quality within our organisation.


This role will involve monitoring, maintaining and improving our purpose-built Quality Management System in accordance with ISO 13485 and ISO 9001 standards.


  • Key responsibilities include:
  • Ensuring overall compliance to standard operating procedures in line with the QMS.
  • Developing audit programs and plans, performing internal audits and co-ordinating external audits.
  • Identifying, planning and documenting opportunities for improvement in company processes and systems and working with subject matter experts to drive implementation.
  • Managing and processing CAPA related activities.
  • Identifying and advising on relevant standards and regulation for product developments, maintaining up to date libraries of applicable standards and regulation across global markets.
  • Facilitating company and product development risk management in accordance with best practices, including ISO 14971, IEC 60812 and ISO 31000.
  • Facilitating appropriate identification and records of product user needs, requirements verification and validation activities and traceability throughout development.
  • Managing quality for the development of medical devices according to regulation such as CE MDR, FDA and TGA and standards including ISO 13485, IEC 60601 and IEC 62304.
  • Managing the calibration of test and measurement equipment.
  • Selecting and evaluating suppliers, monitoring quality agreements, and managing actions arising from goods inspection.
  • Developing and conducting induction and training on QMS processes and policies, and promoting QMS regulatory requirements to all staff.

About This Opportunity

This is an exciting opportunity to join a leading product design team and contribute to the development of innovative, human-centric products.


As a Quality Assurance professional, you will play a critical role in ensuring the delivery of high-quality products that meet customer needs and regulatory requirements.


You will work closely with cross-functional teams to identify and implement process improvements, and develop and maintain quality management systems and processes.


Requirements
  • A relevant qualification from a reputable education organisation.
  • 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 a variety of 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.

Preferred Skill And Experience
  • ISO 17955 Lead Auditor certified.
  • Quality management experience in product design and development.

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