Medical Device Quality Assurance Professional

6 days ago

Singapore beBeeQualityManagement Full time $90,000 - $120,000
Job Title: Quality Management Specialist

As a Quality Management Specialist, you will play a crucial role in ensuring the effectiveness and adequacy of our Quality Management System (QMS). You will be responsible for monitoring and reporting on the QMS, promoting awareness of regulatory requirements, managing document control, engineering change control, and records control process.

Responsibilities:
  • Monitor and report on the QMS to ensure its continuing suitability.
  • Promote awareness of applicable, new, and updated regulations and standards.
  • Manage document control, engineering change control, and records control process.
  • Evaluate, monitor, and re-evaluate suppliers.
  • Manage internal audit program to ensure timely execution.
  • Manage calibration program to ensure all monitoring and measuring equipment are inducted, calibrated, reviewed, and monitored in a timely manner.
  • Participate in design control, risk management, and software development activities throughout the lifecycle of medical devices.
  • Participate in validation of analytical test methods, process validations, and computer software used in the quality management system, production, and monitoring/testing.
  • Participate in handling non-conforming products including but not limited to investigation, corrective/preventive actions, and disposition of affected products.
  • Participate in preparation of premarket regulatory submissions for commercial distribution.

Qualifications:
  • Bachelor of Science degree in a scientific or engineering discipline.
  • Minimum of 3 years of quality management system (ISO) experience in the medical device industry. IVD experience is highly preferred.
  • Direct experience in design and development, and risk management of medical device products are strongly preferred.
  • Strong verbal and written communication skills. Conversational mandarin is preferred.
  • Strong analytical, time management and organizational skills.
  • Proficient in MS Office applications.
  • Have a positive, proactive, can-do attitude, willing to learn.

Skills and Qualifications:
  • Microbiology
  • Investigation
  • Quality Management
  • ISO
  • Manufacturing
  • Software Development
  • Calibration
  • Risk Assessment
  • Regulatory Requirements
  • Regulatory Submissions

  • Medical Device Quality Assurance Specialist

    1 week ago

    Singapore beBeeQualityAssurance Full time $90,000 - $120,000

    Job Title: Medical Device Quality Assurance Specialist"> Job Summary:">This is an exciting opportunity to work as a Medical Device Quality Assurance Specialist, where you will be responsible for ensuring the quality of medical devices. You will be part of a team that works closely with suppliers and customers to ensure that products meet regulatory...

  • Medical Device Quality Assurance Specialist

    6 days ago

    Singapore beBeeQuality Full time $90,000 - $120,000

    Job Description:We are seeking a skilled professional to lead our medical device quality assurance team.The ideal candidate will have experience in performing visual, dimensional, and functional inspections of components and/or finished medical device products.Key Responsibilities:Perform thorough inspections of devices to ensure conformance with design...

  • Medical Device Quality Assurance Specialist

    2 weeks ago

    Singapore beBeeQuality Full time $80,000 - $150,000

    Medical Device Quality Assurance ProfessionalWe are seeking a skilled Medical Device Quality Assurance Professional to join our team.This is a pivotal role that involves monitoring and reporting on the adequacy, effectiveness, and continuing suitability of our Quality Management System (QMS) in accordance with ISO 13485:2016 established policies/procedures,...

  • Senior Quality Assurance Manager

    6 days ago

    Singapore beBeeQuality Full time $90,000 - $120,000

    Medical Device Quality Assurance SpecialistWe are seeking a highly skilled Medical Device Quality Assurance Specialist to join our team.Job Description:This is a unique opportunity to leverage your quality management expertise in the medical device industry. As a Medical Device Quality Assurance Specialist, you will be responsible for ensuring compliance...

  • Medical Device Quality Assurance Specialist

    5 days ago

    Singapore beBeeInspector Full time $40,000 - $55,000

    Medical Device Inspector RoleWe are seeking a highly motivated Medical Device Inspector to join our team in Singapore. In this role, you will be responsible for performing visual, dimensional, and functional inspection of components and/or finished medical device products.Your tasks will include:Conducting inspections using a wide variety of tools and...

  • Medical Device Quality Assurance Inspector

    6 days ago

    Singapore beBeeInspector Full time $4,000 - $6,000

    This is a critical quality assurance role where you will be responsible for inspecting medical devices to ensure they meet regulatory and company standards.Key Responsibilities:Perform thorough inspections of components and/or finished medical device products using a variety of tools and equipment to verify conformance with design specifications.Conduct...

  • Medical Device Quality Assurance Professional

    6 days ago

    Singapore beBeeQuality Full time $40,000 - $80,000

    Quality Assurance Specialist Role OverviewWe are seeking a diligent and detail-oriented professional to join our quality assurance team. The successful candidate will be responsible for ensuring that our medical equipment meets the highest standards of quality.

  • Entry-Level Medical Device Quality Assurance Role

    6 days ago

    Singapore beBeeQuality Full time $4,500

    Medical Device Quality Assurance SpecialistWe are seeking a skilled Medical Device Quality Assurance Specialist to join our team. The ideal candidate will have experience in supplier management, quality assurance, and regulatory compliance.Job Description:Manage supplier performance and trends for the APAC regionCollate and analyze post-market quality data...

  • Medical Device Quality Assurance Specialist

    3 days ago

    Singapore beBeeQuality Full time $90,000 - $120,000

    Quality Assurance Specialist in Medical DevicesThe ideal candidate will possess a strong background in quality assurance and experience in the medical device industry. We are seeking a dedicated professional to oversee the implementation and maintenance of product inspection processes, ensuring compliance with country-specific labeling regulations.Key...

  • Medical Device Quality Manager

    1 week ago

    Singapore beBeeAnalyzer Full time $2,000 - $4,000

    Quality Assurance ProfessionalThis position is responsible for ensuring the quality of medical devices in the APAC region.The ideal candidate will have a strong understanding of supplier management, quality management systems, and continuous improvement principles.