Orthopedic Medical Devices Specialist

3 days ago

Singapore beBeeQuality Full time $70,000 - $130,000
Job Summary

We are seeking a talented Quality Assurance Professional with experience in orthopedic medical devices to ensure the highest standards of quality and compliance are met for innovative products. This role plays a pivotal part in establishing and maintaining robust quality management systems (QMS) and regulatory strategies to support product development, clinical trials, and manufacturing processes.


Key Responsibilities:
  • Develop, implement, and maintain a Quality Management System (QMS) compliant with FDA Quality System Regulation (QSR, 21 CFR 820), ISO 13485:2016, and EU MDR 2017/745.
  • Conduct risk assessments (e.g., dFMEA, pFMEA) and failure mode and effects analysis (FMEA) to identify and mitigate potential issues in orthopedic device design and manufacturing.
  • Oversee validation and verification of manufacturing processes and equipment, ensuring design for manufacturability and product reliability.
  • Perform quality control inspections, reviewing specifications for raw materials, intermediate products, and finished orthopedic devices per engineering drawings and SOPs.
  • Manage non-conformance investigations, root cause analysis, and corrective and preventive actions (CAPA) to address defects and ensure product safety.

Regulatory Compliance:
  • Interpret and ensure compliance with U.S. (FDA), EU (MDR), and international regulatory requirements for orthopedic medical devices.
  • Support regulatory submissions, including 510(k), PMA, and CE marking, by preparing documentation and interfacing with regulatory authorities (e.g., FDA, MHRA).
  • Facilitate post-market surveillance, including complaint investigations, trending complaint data, managing recalls, and medical device reporting to regulatory bodies.
  • Coordinate internal and external audits, ensuring readiness for regulatory inspections and supplier evaluations.

Cross-Functional Collaboration:
  • Collaborate with R&D, engineering, and clinical development teams to integrate quality and regulatory requirements into the product development lifecycle, from prototyping to commercialization.
  • Work with suppliers to evaluate and certify their capabilities, ensuring compliance with quality standards for materials used in orthopedic implants and devices.
  • Provide regulatory guidance and training to internal teams to align with current standards and industry trends.

Continuous Improvement:
  • Lead initiatives to reduce product recalls, defects, and associated costs by implementing effective QA processes.
  • Monitor and update quality and regulatory documentation, including Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR).

  • Senior Orthopedic Medical Device QA Professional

    4 days ago

    Singapore beBeeQuality Full time $120,000 - $160,000

    Medical Device Quality Assurance SpecialistOur team is responsible for advancing global orthopedic solutions that improve patient outcomes. We strive to develop and implement robust quality management systems (QMS) compliant with FDA Quality System Regulation (QSR), ISO 13485, and EU MDR regulations to support product development, clinical trials, and...

  • Senior Orthopedic Medical Device QA Professional

    2 days ago

    Singapore beBeeQuality Full time

    Medical Device Quality Assurance Specialist Our team is responsible for advancing global orthopedic solutions that improve patient outcomes. We strive to develop and implement robust quality management systems (QMS) compliant with FDA Quality System Regulation (QSR), ISO 13485, and EU MDR regulations to support product development, clinical trials, and...

  • Senior Orthopedic Medical Device QA Professional

    2 days ago

    Singapore beBeeQuality Full time

    Medical Device Quality Assurance Specialist Our team is responsible for advancing global orthopedic solutions that improve patient outcomes. We strive to develop and implement robust quality management systems (QMS) compliant with FDA Quality System Regulation (QSR), ISO 13485, and EU MDR regulations to support product development, clinical trials, and...

  • Orthopedic Device Quality Assurance Specialist

    3 days ago

    Singapore beBeeQuality Full time $120,000 - $180,000

    Orthopedic Device Quality Assurance SpecialistWe are seeking a highly skilled Orthopedic Device Quality Assurance Specialist to ensure the highest standards of quality and compliance within our organization. This role plays a pivotal part in establishing robust quality management systems (QMS) and regulatory strategies for product development, clinical...

  • Advanced Orthopedic Device Quality Assurance Specialist

    2 days ago

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

    Orthopedic Medical Device Quality Assurance SpecialistWe are seeking a seasoned quality assurance specialist to ensure the highest standards of quality and compliance in our innovative orthopedic medical devices. This role plays a pivotal part in establishing and maintaining robust quality management systems (QMS) and regulatory strategies to support product...

  • Advanced Medical Device Specialist

    6 days ago

    Singapore beBeeOrthopedic Full time $80,000 - $120,000

    Medical Device Sales ProfessionalThe position involves working with a dynamic team to promote and distribute medical devices, specifically orthopedic implants.Responsibilities:Market and distribute various orthopaedic implant systems to surgeons and healthcare institutions.Offer clinical assistance and support during surgical procedures, ensuring proper use...

  • Manager Medical Devices

    4 days ago

    Singapore DKSH Full time

    **Location**:Jalan Buroh, SG, SG**Job Function**:Sales**Requisition Number**:140146**Description**: **General Responsibilities** - Ensure continuity in good customer relationships by building trust and credibility with customers through effective and professional support. - Organize and conduct product demonstration to customers. - Organize and conduct talks...

  • Medical Device Specialist

    1 week ago

    Singapore beBeeEngineering Full time $120,000 - $180,000

    Job Title: Medical Device SpecialistA key contributor to our organization, the Medical Device Specialist will play a pivotal role in designing, developing, and testing medical devices and equipment.Primary Responsibilities:Develop innovative medical devices and equipment, incorporating cutting-edge technologies and materialsEvaluate and analyze data from...

  • Customer Success Specialist

    1 week ago

    Singapore KINEXCS PTE. LTD. Full time

    Customer Success Specialist (Orthopedic Nurse/Physiotherapist) **About the job Kinexcs is an AI-driven health platform & wearables company enabling and empowering people for mobility and a better quality of life. The company is focused on reducing the burden of musculoskeletal conditions, which affects about 25% of the global population, and is marketing...

  • Compassionate Orthopedic Nurse

    3 days ago

    Singapore beBeeNursing Full time $4,500 - $6,150

    Orthopedic Nursing SpecialistAs an experienced orthopedic nursing specialist, you will be working in a healthcare setting focused on delivering high-quality patient care.Key Responsibilities:Provide comprehensive nursing care to patients, adhering to clinical policies and procedures.Assist physicians during examinations and treatments, including managing...