Senior Quality Assurance Manager

1 day ago

Cebu City, Central Visayas, Philippines beBeeQuality Full time ₱4,000,000 - ₱5,000,000

Job Title: Quality Assurance Specialist

We are seeking a highly skilled professional to champion quality within our organisation, ensuring the delivery of high-quality products and services that meet or exceed customer expectations.

The successful candidate will be responsible for monitoring, maintaining and improving our purpose-built Quality Management System in accordance with ISO 13485 and ISO 9001 standards.

This role is ideal for a motivated and experienced individual who is passionate about creating innovative, human-centric products and wants to do it as part of one of Australia's leading product design teams.

Main Responsibilities:

  • Championing quality within the organisation, towards fulfilling our corporate mission.
  • 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.
  • 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.

Requirements:

  • A relevant qualification from a reputable education institution.
  • 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 Skills and Experience:

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

Location: Remote - Manila

Employment Type: Permanent Full-Time or Contract

Job Function: Quality Assurance

Industries: Design Services

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