Current jobs related to Lead Quality Assurance Specialist - Ballerup, Ballerup Kommune - Ambu

  • Senior Quality Assurance Specialist

    3 weeks ago

    Ballerup, Ballerup Kommune, Denmark DISCREADIS - Dansk IngeniørService AS Full time

    We are seeking a highly skilled Quality Assurance Specialist to join our team at DIS. As a key member of our Quality Assurance team, you will be responsible for ensuring the quality and integrity of our products and services.Your Key ResponsibilitiesDevelop and implement quality assurance strategies to ensure compliance with regulatory requirements.Conduct...

  • Senior Quality Assurance Specialist for Quality Control

    3 weeks ago

    Ballerup, Ballerup Kommune, Denmark Genmab Full time

    About the RoleGenmab is seeking a highly skilled and experienced Senior Quality Assurance Specialist for Quality Control to join our GMP Quality Assurance team in Denmark. As a key member of our team, you will be responsible for ensuring the quality and compliance of our products, collaborating with internal stakeholders and contract manufacturers, and...

  • Quality Assurance Specialist

    3 weeks ago

    Ballerup, Ballerup Kommune, Denmark Novo Nordisk Full time

    About the RoleWe are seeking a highly skilled and experienced Quality Assurance Specialist to join our team at Novo Nordisk. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our pharmaceutical products.Key ResponsibilitiesReview and approve batch documentation for blend and tablet batches to ensure...

  • Quality Assurance Specialist

    1 month ago

    Ballerup, Ballerup Kommune, Denmark Novo Nordisk Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team in Måløv. As a key member of our QA team, you will play a crucial role in ensuring the quality and compliance of our tablet production processes.Key ResponsibilitiesReview and approve batch documentation for blend and tablet batches to ensure correct production...

  • Quality Assurance Lead

    1 week ago

    Ballerup, Ballerup Kommune, Denmark GN Group Full time

    About the Role:FalCom, a subsidiary of the GN Group, is a leading provider of advanced hearing protection solutions. We are seeking a Quality Assurance Manager to join our team and ensure that our products and services meet the highest standards of quality and regulatory compliance.Key Responsibilities:Develop and implement quality management systems and...

  • Quality Assurance Specialist

    5 days ago

    Ballerup, Ballerup Kommune, Denmark Novo Nordisk Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team in Måløv. As a key member of our QA team, you will be responsible for ensuring the quality and compliance of our tablet production processes.Key ResponsibilitiesReview batch documentation for blend and tablet batches to ensure correct production processes and...

  • Quality Assurance Specialist

    2 weeks ago

    Ballerup, Ballerup Kommune, Denmark Elanco Full time

    At Elanco, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.We pride ourselves on fostering a diverse and inclusive work environment, where diversity is the driving force behind innovation, creativity, and overall business success.As a quality contact for the Elanco Affiliate...

  • Quality Assurance Specialist

    3 weeks ago

    Ballerup, Ballerup Kommune, Denmark Novo Nordisk Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Novo Nordisk. As a key member of our QA team, you will play a critical role in ensuring the quality and compliance of our pharmaceutical products.Key ResponsibilitiesReview and approve batch documentation for blend and tablet batches to ensure correct production...

  • Quality Assurance and Validation Specialist

    1 month ago

    Ballerup, Ballerup Kommune, Denmark DISCREADIS - Dansk IngeniørService AS Full time

    About the RoleWe are seeking a highly skilled Quality Assurance and Validation Engineer to join our team at DIS/CREADIS - Dansk IngeniørService A/S. As a key member of our team, you will play a crucial role in ensuring the quality and compliance of our products and services.Key ResponsibilitiesDevelop and review GMP documents to ensure compliance with...

  • Senior Quality Assurance Specialist

    4 days ago

    Ballerup, Ballerup Kommune, Denmark GN Store Nord AS Full time

    About the RoleWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at GN Store Nord A/S. As a key member of our QA team, you will be responsible for ensuring the highest quality of our products and services.Key ResponsibilitiesDevelop and execute comprehensive test plans to ensure application functionality, usability, and...

  • Advanced IT Quality Assurance Specialist

    4 weeks ago

    Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full time

    Job Title: Advanced IT Quality ProfessionalJob Summary:We are seeking an experienced Advanced IT Quality Professional to join our team in Novo Nordisk A/S. As a key member of our IT Quality Assurance team, you will be responsible for providing IT QA subject matter expertise in the GMP domain to projects, systems, and services with a focus on key quality...

  • IT Quality Assurance Assistant

    2 weeks ago

    Ballerup, Ballerup Kommune, Denmark GN Group Full time

    IT Quality Assurance Assistant OpportunityWe are seeking a motivated and detail-oriented IT Quality Assurance Assistant to join our team at GN Group. As an IT Quality Assurance Assistant, you will play a crucial role in supporting our IT QA & Compliance team in ensuring the quality and integrity of our products and services.Your Key ResponsibilitiesSupport...

  • IT Quality Assurance Assistant

    1 month ago

    Ballerup, Ballerup Kommune, Denmark GN Group Full time

    Join Our Team as a Student IT Quality Assurance AssistantWe are seeking a motivated and detail-oriented student to join our IT Quality Assurance team as a Student IT Quality Assurance Assistant. In this role, you will have the opportunity to work closely with our IT executives and stakeholders to support the development and implementation of quality...

  • Advanced Quality Assurance Specialist

    2 days ago

    Ballerup, Ballerup Kommune, Denmark Novo Nordisk Full time

    About the RoleWe are seeking an Advanced Quality Assurance Professional to join our team at Novo Nordisk. As a key member of our QA department, you will play a vital role in ensuring the highest quality standards in pharmaceutical production.Key ResponsibilitiesReview and release of Tablet batches.Approval of documentation, such as deviations, change...

  • Senior Quality Assurance Manager

    1 month ago

    Ballerup, Ballerup Kommune, Denmark KMD AS Full time

    About the RoleWe are seeking a highly skilled Senior Test Manager to join our consultancy team at KMD Services, within the Application Development & Modernization department. As a Senior Test Manager, you will play a key role in advising and assisting clients with their challenges, from small advisory and pilot projects to large, long-term modernization and...

  • Senior Quality Assurance Specialist

    5 days ago

    Ballerup, Ballerup Kommune, Denmark Ambu Full time

    Are you looking for a challenge as a quality professional in the medical device industry? Do you have a passion for quality management and compliance?We are seeking an experienced Head of Global Quality Management Operations to join our pioneering Quality Management team. This is an excellent opportunity to work in a dynamic and international environment,...

  • Quality Assurance Manager

    1 month ago

    Ballerup, Ballerup Kommune, Denmark Ambu Full time

    Head of Global Quality Management OperationsAmbu is seeking a highly skilled and experienced professional to lead our Global Quality Management Operations team. As Head of Global Quality Management Operations, you will be responsible for ensuring the quality and regulatory compliance of Ambu products and processes across the organization.Key...

  • Software Quality Assurance Specialist

    5 days ago

    Ballerup, Ballerup Kommune, Denmark Concardis Full time

    Software Tester - Android & iOSDate Posted: Industry: Financial ServicesJob area: IT & TechnologyCompany DescriptionAbout us and our teamThe eID Solutions business, comprising over 200 colleagues, is at the forefront of creating secure identity solutions and new innovative services of tomorrow leveraging modern technology. Our state-of-the-art solutions...

  • Senior Quality Assurance Manager

    3 weeks ago

    Ballerup, Ballerup Kommune, Denmark Ambu Full time

    Head of Global Quality Management OperationsAmbu is seeking a highly skilled and experienced professional to lead our Global Quality Management Operations team. As Head of Global Quality Management Operations, you will be responsible for ensuring quality and regulatory compliance of Ambu products and processes across the organization.Key...

  • Senior Quality Assurance Manager

    3 weeks ago

    Ballerup, Ballerup Kommune, Denmark Ambu Full time

    Head of Global Quality Management OperationsAmbu is seeking a seasoned quality professional to lead our Global Quality Management Operations team. As Head of Global Quality Management Operations, you will be responsible for ensuring the quality and regulatory compliance of Ambu products and processes across the organization.Key Responsibilities:Develop and...

Lead Quality Assurance Specialist

2 months ago

Ballerup, Ballerup Kommune, Denmark Ambu Full time

Are you passionate about ensuring quality and compliance in the Medical Device sector? Do you have a knack for nurturing talent and fostering team development? If so, this role could be a perfect fit for you.

Position Overview

In this pivotal role, you will be an integral part of a high-performing team of 8 skilled Quality Management professionals. Your primary focus will be to uphold quality and regulatory standards for Ambu's products and processes throughout the organization, with a specific emphasis on the oversight of supplier quality in sterilization services.

Key Responsibilities

Your duties will encompass:

  • Evaluating supplier quality for sterilization services
  • Assisting in Post-Market Surveillance (PMS), trend analysis, and monitoring activities
  • Conducting training sessions on compliance processes
  • Enhancing the performance of the Quality System within QA Processes
  • Participating in global quality forums to advocate for proactive process enhancements
  • Supporting various processes and tasks within Quality Assurance and Supplier Quality Management
  • Executing or assisting with Quality Audits (Internal/External/Suppliers) as per the audit schedule or upon request
  • Providing Quality Assurance insights for Supplier Controls: Evaluation, Monitoring, and Re-evaluation

Ideal Candidate Profile

We recognize that skills and experiences can be acquired through various avenues, and the ideal candidate may not fit a conventional mold. However, you are likely to excel in this position if you possess:

  • A relevant academic qualification, such as a BSc, MSc, or Engineering degree
  • A minimum of 5-10 years of experience in a quality-focused role within the Medical Devices field
  • Proven experience with Corrective and Preventive Actions (CAPAs), Non-Conformance Reports (NCRs), and Supplier Quality Management (SQM)
  • Comprehensive knowledge of pertinent regulations for medical devices, including ISO13485, EU MDR, MDSAP, and UK MD
  • A strong commitment to quality and a focus on business collaboration within the organization

About Ambu

Ambu is a rapidly growing company with ambitious objectives. We achieve these goals through collaborative efforts among motivated and highly skilled individuals. Your contributions are vital to our success, and by becoming part of our team, you will have the opportunity to work in an international environment that values informal collaboration.

We provide excellent opportunities for personal growth and a comprehensive range of professional, social, and financial benefits, alongside engaging job challenges and ongoing professional and personal development.