Quality Manager

3 days ago

Makati City, National Capital Region, Philippines beBeeQuality Full time ₱800,000 - ₱1,000,000

The Role: Quality Assurance Specialist

This role is responsible for leading and supporting the organization's quality management processes and team.

Key Responsibilities:
  • Quality Champion: Championing quality within the organization, towards fulfilling our corporate mission.
  • System Maintenance: Monitoring, maintaining and improving our purpose-built Quality Management System in accordance with ISO 13485 and ISO 9001 standards.
  • Compliance Oversight: Ensuring overall compliance to standard operating procedures in line with the QMS.
  • Audit Planning: Developing audit programs and plans, performing internal audits and co-ordinating external audits.
  • Process Improvement: Identifying, planning and documenting opportunities for improvement in company processes and systems and working with subject matter experts to drive implementation.
  • CAPA Management: Managing and processing CAPA related activities.
  • Regulatory Guidance: Identifying and advising on relevant standards and regulation for product developments, maintaining up to date libraries of applicable standards and regulation across global markets.
  • Risk Management: Facilitating company and product development risk management in accordance with best practices, including ISO 14971, IEC 60812 and ISO 31000.
  • Product Development: Facilitating appropriate identification and records of product user needs, requirements verification and validation activities and traceability throughout development.
  • Medical Device Compliance: 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.
  • Equipment Calibration: Managing the calibration of test and measurement equipment.
  • Supplier Evaluation: Selecting and evaluating suppliers, monitoring quality agreements, and managing actions arising from goods inspection.
  • Training and Induction: Developing and conducting induction and training on QMS processes and policies, and promoting QMS regulatory requirements to all staff.
Requirements:
  • Education: Relevant qualification from a reputable education organisation.
  • Experience: At least 5 years' experience in quality management or a similar role.
  • Knowledge: In-depth knowledge of ISO 13485 and ISO 9001, as well as regulatory requirements pertaining to product development.
  • Production Knowledge: Understanding of a variety of production/manufacturing processes.
  • Sourcing Experience: Experience in communicating with and evaluating local and offshore suppliers.
  • Communication Skills: Excellent verbal and written English communication skills.
  • Teamwork: Ability to work independently and as part of a team.

This role requires the ability to communicate effectively with various stakeholders, manage multiple priorities, and maintain accurate records. The ideal candidate will have excellent problem-solving skills, be proactive, and have a passion for quality assurance.

The successful candidate will be responsible for developing and implementing quality management systems, ensuring compliance with regulatory requirements, and identifying areas for process improvement. They will also be responsible for providing guidance and support to colleagues on quality-related matters.

If you are a motivated and organized individual with a strong background in quality management, we encourage you to apply for this exciting opportunity.

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