Chief Quality Control Officer

2 weeks ago

Manila, National Capital Region, Philippines beBeeQuality Full time ₱70,283 - ₱80,836
Job Title:

Quality Assurance Specialist

Key Responsibilities:
  • Champion quality within the organization, ensuring alignment with corporate objectives.
  • Develop and implement Quality Management Systems, adhering to ISO 13485 and ISO 9001 standards.
  • Monitor and maintain compliance with standard operating procedures, ensuring seamless integration with QMS.
  • Design and execute audit programs, facilitating internal and external audits.
  • Identify and prioritize opportunities for process improvements, collaborating with subject matter experts to drive implementation.
  • Manage CAPA related activities, ensuring prompt resolution of non-conformities.
  • Stay up-to-date with relevant standards and regulations, maintaining comprehensive libraries for global markets.
  • Facilitate risk management across company and product development, aligning with best practices.
  • Ensure user needs, requirements verification, and validation are accurately captured and recorded throughout development.
  • Oversee quality for medical device development, adhering to regulatory requirements such as CE MDR, FDA, and TGA, as well as standards including ISO 13485, IEC 60601, and IEC 62304.
  • Manage test and measurement equipment calibration, ensuring accuracy and precision.
  • Evaluate suppliers, monitor quality agreements, and manage actions arising from goods inspection.
  • Develop and conduct training on QMS processes and policies, promoting regulatory awareness among staff.
Required Skills and Qualifications:
  • A relevant qualification from a reputable educational 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 pertinent to product development.
  • Familiarity with various production/manufacturing processes.
  • Experience in communicating with and evaluating local and offshore suppliers.
  • Excellent verbal and written communication skills.
  • Ability to work independently and collaboratively as part of a team.
Benefits:
  • Work on diverse product ranges, showcasing expertise in design.
  • Contribute to creating innovative, human-centric products.
  • Be part of a leading product design team in Australia.
  • Enjoy workplace flexibility, allowing remote work arrangements.
  • Access to comprehensive design services and multidisciplinary support.
Join Our Team:

Apply now to take your career to the next level and become an integral part of our team. We look forward to reviewing your application.

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