Senior Quality Assurance Specialist

2 weeks ago

Porac, Philippines beBeeQuality Full time ₱80,000 - ₱120,000
Quality Management Specialist

Job Description:

Lead and support the Quality Management processes and team to champion quality within the organisation, ensuring compliance to standard operating procedures in line with the QMS.

Key responsibilities include monitoring, maintaining and improving the purpose-built Quality Management System in accordance with ISO 13485 and ISO 9001 standards. This involves developing audit programs and plans, performing internal audits and coordinating external audits.

Additionally, you will identify, plan and document opportunities for improvement in company processes and systems, working with subject matter experts to drive implementation. Managing and processing CAPA related activities is also a key aspect of this role.

Responsibilities also include identifying and advising on relevant standards and regulations for product developments, maintaining up-to-date libraries of applicable standards and regulations across global markets.

Furthermore, you will facilitate company and product development risk management in accordance with best practices, including ISO 14971, IEC 60812 and ISO 31000.

Another important responsibility is 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 is also crucial.

Finally, you will be responsible for managing the calibration of test and measurement equipment, selecting and evaluating suppliers, monitoring quality agreements, and managing actions arising from goods inspection.

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 Qualifications:
  • Quality management experience in product design and development.

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