Current jobs related to Medical Device Compliance Specialist - Kitchener, Ontario - Demant Polska

  • Medical Device Compliance Specialist

    1 week ago

    Kitchener, Ontario, Canada Demant Polska Full time

    Job DescriptionWe are seeking a skilled Medical Device Compliance Specialist to oversee quality activities, ensuring compliance with applicable medical device regulations. The ideal candidate will possess excellent organizational and communication skills.ResponsibilitiesCoordinate inventory control, logistics, and supply chain processes to align operational...

  • Medical Device Quality Assurance Expert

    1 week ago

    Kitchener, Ontario, Canada Demant Polska Full time

    At Demant Polska, we are seeking an experienced Operations and Quality Assurance Specialist to oversee and optimize quality activities for a manufacturer of medical devices. As an expert in quality management systems and regulatory requirements, you will ensure compliance with applicable medical device regulations and reporting requirements.Key...

  • Senior Medical Device Development Manager

    6 days ago

    Kitchener, Ontario, Canada Vena Medical Full time

    Vena Medical is a leading innovator in stroke treatment, revolutionizing the medical field with cutting-edge catheter-based technologies. Our flagship products, the Vena MicroAngioscope and the Vena Balloon Distal Access Catheter, provide neurointerventional physicians with advanced tools for treating stroke. As we continue to expand our product line and...

  • Medical Device Quality Engineer

    2 weeks ago

    Kitchener, Ontario, Canada FluidAI Medical Full time

    About the RoleThis position requires a highly skilled Quality Engineer to join our high-performing QA and Design/Development team.The successful candidate will work closely with the QA/RA Manager and the technical team in the development, implementation, and operation of the Quality System for the control of FluidAI Medical's medical devices.Key...

  • Regulatory Expert for Medical Devices

    1 week ago

    Kitchener, Ontario, Canada Demant Polska Full time

    Job OverviewWe are seeking a Quality Assurance and Operations Manager to lead our quality team, ensuring compliance with applicable medical device regulations. The ideal candidate will possess excellent leadership and communication skills.ResponsibilitiesLead the quality team, overseeing inventory control, logistics, and supply chain processes to ensure...

  • Medical Data Storyteller

    2 weeks ago

    Kitchener, Ontario, Canada FluidAI Medical Full time

    Transforming Post-Operative Care through Data-Driven CommunicationWe are seeking a talented Marketing and Communications Specialist to join our team at FluidAI Medical. This role offers a unique opportunity to leverage your expertise in graphic design, visual storytelling, and data-driven marketing to craft compelling narratives that resonate with...

  • Regulatory Compliance Expert

    2 weeks ago

    Kitchener, Ontario, Canada FluidAI Medical Full time

    Benefits of Working at FluidAI MedicalA fast-paced, technical environment with new and interesting challenges every day.A passionate team dedicated to delivering life-changing medical devices.A comprehensive training program with access to workshops, coursework, and experienced mentors/consultants.An equal opportunity employer with a diverse team...

  • Medical Device Operations Coordinator

    4 days ago

    Kitchener, Ontario, Canada Intellijoint Surgical Inc Full time

    About Us:">At Intellijoint Surgical Inc, we are passionate about developing innovative medical devices that enhance surgical outcomes and improve patient quality of life. Our technology has been used in over 60,000 surgeries, and we continue to push the boundaries of what is possible.We are seeking a highly skilled Field Operations Manager to join our...

  • Medical Device Research Professional

    22 hours ago

    Kitchener, Ontario, Canada FluidAI Full time

    About Us:At FluidAI Medical, we are committed to revolutionizing post-operative care with cutting-edge technology. Our medical device organization combines innovation with compassion to deliver better patient outcomes.Job Role:The Senior Clinical Research Associate will be responsible for supporting the design, initiation, execution, management, data...

  • Medical Device Clinical Trials Coordinator

    2 weeks ago

    Kitchener, Ontario, Canada FluidAI Full time

    Introduction    FluidAI Medical is dedicated to transforming post-operative care through innovative medical device solutions. We are now seeking an experienced Clinical Research Associate to join our team and contribute to the success of our clinical trials.Key Responsibilities    The successful candidate will be responsible for:Sourcing and...

  • Marketing & Communication Specialist (Marcomm Specialist) (High Salary)

    2 weeks ago

    Kitchener, Ontario, Canada FluidAI Medical Full time

    Company Description:FluidAI Medical is creating a paradigm shift in post-operative care, utilizing the plethora of data within the body to help in the detection of post-operative complications at their onset. Our clinically validated platform sensing technology augments existing wound drains and catheters, providing healthcare providers with a smart...

  • Quality Engineer 3 Days Left

    3 weeks ago

    Kitchener, Ontario, Canada FluidAI Medical Full time

    FluidAI Medical is creating a paradigm shift in post-operative care, utilizing the plethora of data within the body to help in the detection of post-operative complications at their onset. Our clinically validated platform sensing technology augments existing wound drains and catheters, providing healthcare providers with a smart monitoring tool that can...

  • Operations and Quality Assurance Specialist

    2 weeks ago

    Kitchener, Ontario, Canada Demant Polska Full time

    Operations and Quality Assurance SpecialistWe are seeking an experienced Operations and Quality Assurance Specialist to oversee and optimize quality activities for a manufacturer of medical devices, assuring compliance with applicable medical device regulations, guidance, and standards. The ideal candidate will be detail-oriented, proactive, and possess...

  • Principal Research and Development Engineer

    6 days ago

    Kitchener, Ontario, Canada Vena Medical Full time

    Vena Medical is committed to advancing medical treatments and improving patients' lives by developing innovative catheter-based technologies. Our flagship products, the Vena MicroAngioscope and the Vena Balloon Distal Access Catheter, provide neurointerventional physicians with advanced tools for treating stroke. As we continue to expand our product line and...

  • Quality Assurance Specialist Lead

    2 weeks ago

    Kitchener, Ontario, Canada Demant Polska Full time

    Job DescriptionWe are seeking an experienced Quality Assurance Specialist Lead to oversee and optimize quality activities for a manufacturer of medical devices, ensuring compliance with applicable medical device regulations and standards. The ideal candidate will be detail-oriented, proactive, and possess excellent organizational and communication skills.Key...

  • Operations and Compliance Officer

    2 weeks ago

    Kitchener, Ontario, Canada Demant Polska Full time

    About the JobWe are seeking a highly skilled Operations and Compliance Officer to join our team at Demant Polska. In this role, you will be responsible for ensuring the highest level of quality and compliance in all aspects of our operations. You will work closely with cross-functional teams to identify and implement process improvements, manage inventory...

  • Marketing and Communications Expert

    2 weeks ago

    Kitchener, Ontario, Canada FluidAI Medical Full time

    Crafting Compelling Narratives for Medical InnovationWe are seeking a skilled Marketing and Communications Specialist to join our team at FluidAI Medical. In this role, you will have the opportunity to leverage your expertise in graphic design, visual storytelling, and data-driven marketing to develop compelling narratives that showcase our innovative...

  • Healthcare Marketing Specialist

    7 days ago

    Kitchener, Ontario, Canada FluidAI Medical Full time

    Job OverviewWe are seeking a Marketing and Communication Specialist (Marcomm Specialist) with a strong medical and analytical background who excels in graphic design, visual storytelling, data-driven marketing, and digital marketing strategy. This role is perfect for a creative problem-solver who can bridge the gap between scientific insights and compelling...

  • Business Development Funding Expert

    2 weeks ago

    Kitchener, Ontario, Canada FluidAI Medical Full time

    About FluidAI Medical">We are a pioneering healthcare company harnessing the power of data to revolutionize post-operative care. Our innovative platform, integrating with existing medical devices, empowers healthcare professionals to detect complications early and enhance patient outcomes.Why Join Us?Mission-driven team committed to saving lives through...

  • Healthcare Insights Specialist

    2 weeks ago

    Kitchener, Ontario, Canada FluidAI Medical Full time

    We're looking for a skilled Data Scientist to help us make a meaningful impact in post-operative care. Our clinically validated platform is designed to detect complications early on, empowering healthcare providers to deliver better care.About the RoleIn this exciting opportunity, you'll work in a hybrid environment, balancing remote flexibility with...

Medical Device Compliance Specialist

3 weeks ago

Kitchener, Ontario, Canada Demant Polska Full time
About the Role

The Operations and Quality Assurance Specialist is responsible for ensuring that all quality-related activities are conducted in accordance with regulatory requirements and company policies. This includes coordinating inventory control, maintaining QMS procedures, and participating in external audits.

Responsibilities:
  1. Develop and implement quality management systems to ensure compliance with regulatory requirements.
  2. Conduct regular audits to ensure accuracy of inventory records and QMS procedures.
  3. Collaborate with cross-functional teams to resolve customer and supplier disputes.
  4. Develop and maintain KPI reports to track quality performance.
  5. Ensure compliance with regulatory requirements through regular monitoring and updates.
Requirements

To be successful in this role, you must have a minimum of 1+ year of experience in a quality role with experience in quality management systems/MDEL and regulatory requirements, ISO within a manufacturing or distribution environment, preferably in medical devices.

You should also possess strong analytical skills, excellent communication and interpersonal skills, and the ability to multitask and prioritize tasks in a fast-paced environment.