Senior Quality Assurance Specialist

1 day ago

Manila, National Capital Region, Philippines beBeeQuality Full time $100,000 - $120,000
Job Description

We are seeking a Senior Quality Assurance Specialist to join our team. The successful candidate will be responsible for championing quality within the organization, ensuring overall compliance to standard operating procedures in line with the QMS.


Responsibilities:
  • Monitor, maintain and improve our purpose-built Quality Management System in accordance with ISO 13485 and ISO 9001 standards.
  • Develop audit programs and plans, perform internal audits and coordinate external audits.
  • Identify opportunities for improvement in company processes and systems, work with subject matter experts to drive implementation.
  • Manage CAPA related activities.
  • Facilitate risk management in accordance with best practices, including ISO 14971, IEC 60812 and ISO 31000.
  • Ensure product user needs, requirements verification and validation activities and traceability throughout development.
  • Manage 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

To be considered for this role, you will require:


  • 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.

Benefits

This role offers:


  • The opportunity to work on challenging projects.
  • A dynamic and supportive work environment.
  • Professional development opportunities.

About Us

We provide comprehensive design services to leading Australian and international companies for a wide range of industries. Our development team spans industrial and mechanical design, electronics, embedded, iOS, Android, Linux app, web servers and more. We provide a full turnkey service for our customers and a unique opportunity for creative, passionate, professional designers and engineers to continue to develop their skills with us.

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