Product Safety Specialist

2 days ago

San Juan, National Capital Region, Philippines beBeeQuality Full time $85,000 - $105,000
Job Description

As a Quality Assurance Lead, you will champion quality and drive towards fulfilling our corporate mission.

You will be responsible for monitoring, maintaining and improving our purpose-built Quality Management System in accordance with ISO 13485 and ISO 9001 standards. Ensuring overall compliance to standard operating procedures in line with the QMS.

Key responsibilities include 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, 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. Facilitating company and product development risk management in accordance with best practices, including ISO 14971, IEC 60812 and ISO 31000.

Ensuring 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.

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 communication skills.
  • Ability to work independently and as part of a team.
Preferred Qualifications
  • ISO 17955 Lead Auditor certified.
  • Quality management experience in product design and development.

Be part of a multi-disciplinary product development consulting team, providing comprehensive design services to leading Australian and international companies.

This is an opportunity for creative, passionate, professional designers and engineers to develop their skills.

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