Medical Quality Assurance Professional

il y a 2 semaines


Mechelen, Flandre, Belgique Nipro Corporation - Global Temps plein

About the role:

As a Senior Quality Assurance Specialist at Nipro Corporation - Global, you will play a critical role in driving innovation in the healthcare industry. You will be responsible for ensuring the development and compliance of medical products with the highest standards of quality, safety, and regulatory requirements.

This is an excellent opportunity to join a team that is passionate about delivering high-quality products and services. As a key member of our team, you will contribute to the development of products that meet the needs of patients and customers worldwide.

You will report to the VP RAQACA with dotted line to the VP R&D EMEA. Your primary responsibilities will include:

  • Quality Assurance (60%)
    • Ensure product compliance with CE, ISO13485, MDR, product standards, and environmental requirements.
    • Maintain accurate and detailed records of quality assurance activities.
    • Identify and document quality issues and recommend solutions.
    • Train and support staff on quality assurance processes and best practices.
    • Conduct regular inspections and quality tests.
    • Develop and implement risk mitigation strategies.
  • Project Management (15%)
    • Closely cooperate with Nipro Corporate Japan, R&D Japan, and suppliers of products and parts.
  • Governance & Compliance (10%)
    • Develop and implement quality policies and procedures.
    • Monitor and report on quality performance.
  • QMS Maintenance and Audit Support (15%)
    • Conduct regular risk assessments and audits.
    • Prepare and support internal and external audits for ISO 13485, MDR, and ISO 14001.
    • Ensure timely resolution of audit findings and recommendations.
    • Maintain documentation and evidence for audit purposes.

Requirements:

  • Experience in Quality Assurance, particularly in the R&D medical device industry.
  • Knowledge of CE, ISO13485, MDR, and other relevant standards.
  • Strong project management skills.
  • Excellent communication and collaboration skills.
  • Ability to train and coach staff on quality assurance processes.
  • Detail-oriented with strong problem-solving abilities.

Benefits:

  • Join a team that is at the forefront of innovation in the healthcare industry.
  • Work in a collaborative environment with cross-functional teams.
  • Contribute to the development of products that meet the highest standards of quality, safety, and regulatory compliance.
  • Be part of a company that values quality and continuous improvement.
  • Work in the EMEA HQ of an international company, with 30+ different nationalities.
  • Home working is offered 2 days a week.


  • Mechelen, Flandre, Belgique Nipro Corporation - Global Temps plein

    About the role: You will be working in a team that is passionate about innovation in the (connected) healthcare industry and the products we develop. As a Senior Quality Assurance Specialist, you will be responsible for the Quality strategy and governance, ensuring the development and compliance of the medical products we help design and develop at Nipro....


  • Mechelen, Flandre, Belgique Nipro Corporation - Global Temps plein

    About the role: You will be working in a team that is passionate about innovation in the (connected) healthcare industry and the products we develop. As a Senior Quality Assurance Specialist, you will be responsible for the Quality strategy and governance, ensuring the development and compliance of the medical products we help design and develop at Nipro....


  • Mechelen, Flandre, Belgique beBee Careers Temps plein

    About the PositionWe are seeking a quality-focused professional to join our team as a Quality Assurance Specialist. The ideal candidate will be responsible for ensuring that all products and services meet the highest standards of quality.Key Responsibilities:Ensure that all products and services meet the highest standards of quality.Conduct regular audits to...

  • Quality Assurance Expert

    il y a 1 jour


    Mechelen, Flandre, Belgique beBee Careers Temps plein

    About the JobWe are seeking a highly skilled Quality Assurance expert to ensure the highest standards of quality and compliance in our products and processes. As a total solution provider of medical devices, we are committed to improving patient outcomes and quality of life.About the RoleAs a Quality Assurance expert, you will play a vital role in...

  • Quality Assurance Leader

    il y a 2 jours


    Mechelen, Flandre, Belgique beBee Careers Temps plein

    About the JobThe Regulatory Affairs Vice President will be responsible for leading the RA/QA/CA team, ensuring compliance to quality and regulatory requirements for Medical Devices.Main Responsibilities:Lead the RA/QA/CA team to ensure compliance to quality and regulatory requirements.Develop strategies to ensure compliance with environmental requirements...

  • Quality Systems Expert

    il y a 2 jours


    Mechelen, Flandre, Belgique beBee Careers Temps plein

    Quality Assurance Systems ManagerA senior Quality Assurance Specialist is required to lead the development and implementation of a robust Quality Management System (QMS) that meets corporate and regional EMEA process requirements.Main Responsibilities:Develop, maintain, and implement a QMS that meets process requirements.Collaborate with the QA team to...


  • Mechelen, Flandre, Belgique Nipro Corporation - Global Temps plein

    We are seeking a highly skilled and experienced Quality Assurance Specialist to join our team at Nipro Corporation - Global. As a key member of our team, you will play a critical role in ensuring the development and compliance of medical products with the highest standards of quality, safety, and regulatory requirements.In this role, you will be responsible...


  • Mechelen, Flandre, Belgique beBee Careers Temps plein

    p{font-size: 16px;}This role requires excellent communication and customer service skills, as well as familiarity with GMP and regulatory requirements.Analytical ExpertKey Responsibilities:Ensure compliance with relevant regulatory regulations, analytical methods, and specifications, GMP, and safety standards.Perform scientific evaluation of generated...


  • Mechelen, Flandre, Belgique beBee Careers Temps plein

    Job OverviewWe are seeking a highly skilled Logistics Quality Assurance Specialist to join our team. In this role, you will be responsible for implementing and maintaining our quality management systems, ensuring compliance with regulatory requirements and industry standards.Implementing quality policies and proceduresConducting audits and risk...

  • Medical Equipment Specialist

    il y a 2 semaines


    Mechelen, Flandre, Belgique Hemotech Belux Temps plein

    Hemotech Belux, a leading provider of haemodialysis and extracorporeal treatments, is seeking an experienced Medical Equipment Specialist to join our team.We are looking for a skilled professional who can maintain, repair, and install dialysis equipment and water treatment systems. As a Field Service Engineer, you will work on-site at hospitals and dialysis...

  • Quality Assurance Engineer

    il y a 2 semaines


    Mechelen, Flandre, Belgique Biocartis Temps plein

    About the RoleWe are seeking a highly skilled OMPS/QC Engineer to join our team at Biocartis. As a key member of our quality assurance department, you will be responsible for supporting QC operations, method transfer activities, and infrastructure setup.Your primary focus will be on ensuring the accuracy and reliability of technical reports, investigating...

  • Quality Assurance Specialist

    il y a 2 semaines


    Mechelen, Flandre, Belgique Biocartis Temps plein

    Job DescriptionThe OMPS/QC Engineer supports quality control operations for method transfer activities from development to QC Operations. This role involves setting up and maintaining the QC infrastructure, processes, procedures, and methods related to incoming materials, semi-finished products, and finished products. The OMPS/QC Engineer also assists with...


  • Mechelen, Flandre, Belgique beBee Careers Temps plein

    About the RoleThe ideal candidate will have a strong background in quality management and experience working within the medical device industry. You will be responsible for ensuring compliance with regulatory requirements and maintaining high-quality products and processes.Key ResponsibilitiesDevelop and implement quality management systems in accordance...

  • Quality Specialist

    il y a 2 semaines


    Mechelen, Flandre, Belgique Nipro Europe Group Temps plein

    About the job As a total solution provider of medical devices and pharmaceutical packaging, Nipro Europe Group Companies is continuously committed to improving patient outcomes and quality of life. We are part of a large global network headed by Nipro Corporation Japan, an industry-leading healthcare company with over 35.000 employees worldwide. Our...

  • Medical Product Specialist

    il y a 2 semaines


    Mechelen, Flandre, Belgique Nipro Corporation - Global Temps plein

    As a total solution provider of medical devices and pharmaceutical packaging, Nipro Europe Group Companies is continuously committed to improving patient outcomes and quality of life. We are part of a large global network headed by Nipro Corporation Japan, an industry-leading healthcare company with over 35.Our European headquarters in Mechelen, Belgium...


  • Mechelen, Flandre, Belgique beBee Careers Temps plein

    Job SummaryWe are looking for a highly motivated Software Quality Assurance Manager to join our team. The successful candidate will be responsible for developing and implementing comprehensive testing strategies, ensuring the delivery of high-quality software.Main ResponsibilitiesTranslate strategic plans into team Objectives & Key Results (OKRs).Act as a...


  • Mechelen, Flandre, Belgique beBee Careers Temps plein

    Job SummaryWe are seeking a highly skilled and experienced logistics professional to fill the role of Production Supervisor. The successful candidate will be responsible for supervising production teams and ensuring that all production activities are carried out efficiently and effectively.Main Responsibilities:Oversee daily production activities to ensure...


  • Mechelen, Flandre, Belgique beBee Careers Temps plein

    The Key Account Manager will play a crucial role in developing sales in the assigned sector, promoting pharmaceutical specialties to healthcare professionals, and providing quality information based on scientifically validated data.Key ResponsibilitiesProspect and define targeting in the sector. Identify key experts and establishments.Define and implement...

  • Medical Devices Director

    il y a 2 jours


    Mechelen, Flandre, Belgique beBee Careers Temps plein

    About This OpportunityThis is an exciting opportunity to join our team as a Regulatory Affairs Vice President, where you will lead the RA/QA/CA team to ensure compliance to quality and regulatory requirements for Medical Devices.Main Objectives:Lead the RA/QA/CA team to achieve compliance to quality and regulatory requirements.Develop and implement...


  • Mechelen, Flandre, Belgique Nipro Corporation - Global Temps plein

    About the CompanyNipro Corporation - Global is a leading provider of medical devices and pharmaceutical packaging. We are committed to improving patient outcomes and quality of life through our innovative products and services.We are seeking a highly skilled Senior Clinical Affairs Specialist to join our dynamic team in EMEA HQ. This role will provide an...