Innovation Process Specialist

2 weeks ago

Ballerup, Denmark Ambu Full time

Do you have experience within the Medical Device industry? Do you carry a strong understanding of industry regulations, e.g. FDA and ISO? Do you love to optimize and see opportunities where others see obstacles?

Then this might be your defining moment. Apply today and join us for a career #ForeverForward

Are you driven by improving and streamlining?

You will be a part of a growing Innovation Process Team which focuses on Design Control and Design Change processes, supporting the broader Ambu project management portfolio.

The Innovation Process team is driven by improving and streamlining the work across project management, product development and design control processes. This among other means that we ensure coherent and meaningful processes as well as implementing and supporting the organisation to adapt and adhere to this.

You will have the chance of working with a wide range of stakeholders locally and globally in order to fulfil this mission.

Training and coaching will also be part of your daily work, providing the necessary guidance across the organisation and more particularly in R&D.

Key responsibilities

Design Control Oversight: Lead the development, implementation, and maintenance of R&D design-control processes in compliance with regulatory requirements (FDA, ISO, etc.) Process Improvement: Identify opportunities for process improvements and lead initiatives to enhance efficiency, effectiveness, and compliance within the design control and process framework Project support: Support the development projects in following the processes and support preparation of design control documentation in innovation projects Audit Preparation: Prepare and support internal and external audits related to R&D processes. Implement corrective and preventive actions as needed Cross-functional Collaboration: Work closely with stakeholders within R&D, Quality Assurance, Regulatory Affairs, and other relevant departments to align on best practices and implement regulatory requirements throughout the product lifecycle Training and Development: Provide guidance and training on design control processes, ensuring a thorough understanding of regulatory requirements and adherence to internal policies Problem solving in relation to NCRs, CAPA across R&D

Suggested candidate profile

Skills and experiences can be earned in many different ways, and we understand that the best fit for the role cannot be prescribed on paper. You are however likely to succeed in this position if you have:

Experience with creation and/or implementation of procedures Experience with training, facilitating and coaching users of the procedures Have a can-do mindset, and thrive in collaborating across teams, functions and cultures  A relevant educational background, e.g. Science, Engineering and/or tech. Experience with participation is inspections and/or audits would be a plus Experience with design control in a Medical Device Company is a huge plus

As we're a globally operating company, fluency in English is crucial. 

Apply for a career #ForeverForward

Ambu – a visionary and international workplace where your efforts matter

Ambu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us you will get the opportunity to work in an international head office with an informal working environment.

We offer great opportunities for personal development. Furthermore, we offer a wide range of professional, social and financial employee benefits in addition to exciting job challenges and continuous professional and personal development.

  • Innovative Technical Project Manager for Protection and Metering Systems

    4 weeks ago

    Ballerup, Denmark Siemens Energy Full time

    Innovative Technical Project Manager for Protection and Metering Systems About the Role Location Denmark Hovedstaden Ballerup Company Siemens Energy A/S Organization Grid Technologies Business Unit Grid Solutions Full / Part time Full-time Experience Level Mid-level Professional Siemens Energy is looking for an Innovative Technical Project...

  • Payroll Specialist

    4 weeks ago

    Ballerup, Denmark Siemens Full time

    Er du klar til at skabe en effektiv og strømlinet lønadministration? Vi søger en dygtig Payroll Specialist med fokus på SAP eller som brænder for at tilegne sig denne kompetence.Hos os handler det om at arbejde smartere, ikke hårdere.Vi leder derfor efter en dedikeret person, der kan optimere vores processer og være den drivende kraft i forskellige...

  • Payroll Specialist

    7 days ago

    Ballerup, Denmark Leo Pharma AS Full time

    Your role    As a Payroll Specialist, you will be responsible for delivering best-in-class Payroll services with a human touch. You will be responsible for executing payroll processes in few countries while acting as back up for any of the other countries handled in the team, if needed. The Payroll Specialist position will involve executing the three...

  • Payroll Specialist

    2 weeks ago

    Ballerup, Denmark LEO Pharma Full time

    Your role    As a Payroll Specialist, you will be responsible for delivering best-in-class Payroll services with a human touch. You will be responsible for executing payroll processes in few countries while acting as back up for any of the other countries handled in the team, if needed. The Payroll Specialist position will involve executing the three...

  • Global Process SME and Product Owner

    1 week ago

    Ballerup, Denmark LEO Pharma AS Full time

    Field of work: Supply Chain & ProcurementPosting Date: 7 May 2024Location: Ballerup 2750, Denmark, Denmark Contract type: Permanent Job ID: 2151Are you passionate about process optimization and finding best solutions? This is an opportunity to work in a central role that bridges IT and the business where you will drive optimization and streamlining processes...

  • Global Process SME and Product Owner

    1 week ago

    Ballerup, Ballerup Kommune, Denmark LEO Pharma AS Full time

    Field of work: Supply Chain & ProcurementPosting Date: 7 May 2024Location: Ballerup 2750, Denmark, Denmark Contract type: Permanent Job ID: 2151Are you passionate about process optimization and finding best solutions? This is an opportunity to work in a central role that bridges IT and the business where you will drive optimization and streamlining processes...

  • Regulatory Product Compliance Specialist to Corporate Quality, Group R&D

    1 week ago

    Ballerup, Ballerup Kommune, Denmark Gn Hearing AS Full time

    Would you like to step into position where you ensure a smooth and efficient market access, making a difference for our end users? At GN, we develop innovative hearing solutions with great sound quality and excellent design to ensure that hearing aid users will be able to hear more, do more, and be more. In the role as (Senior) Regulatory Product...

  • Student worker

    7 days ago

    Ballerup, Denmark Bosch Holding ApS Full time

    Job Description Join our Intelligent Process Automation team and be part of revolutionizing our business processes. Don't miss this opportunity to accelerate your career and contribute to our journey of innovation! We're seeking a student worker to support our Europe North organization in leveraging automation technologies for efficiency and innovation....

  • (Senior) Regulatory Product Compliance Specialist to Corporate Quality, Group R&D

    2 weeks ago

    Ballerup, Denmark Gn Hearing AS Full time

    Would you like to step into position where you ensure a smooth and efficient market access, making a difference for our end users? At GN, we develop innovative hearing solutions with great sound quality and excellent design to ensure that hearing aid users will be able to hear more, do more, and be more. In the role as (Senior) Regulatory Product...

  • Student worker

    1 week ago

    Ballerup, Denmark Bosch Rexroth AS Full time

    Job DescriptionJoin our Intelligent Process Automation team and be part of revolutionizing our business processes. Don't miss this opportunity to accelerate your career and contribute to our journey of innovation!We're seeking a student worker to support our Europe North organization in leveraging automation technologies for efficiency and innovation. In...

  • Global Process SME and Product Owner

    1 week ago

    Ballerup, Denmark LEO Pharma Full time

    Your role will include gathering and prioritizing requirements from both business and authorities, leading the implementation of global technical requirements, and ensuring timely and high-quality changes to global processes in a GxP-environment.      Your qualifications You will be collaborating closely with stakeholders across the value chain....

  • IC Tool Flow Specialist

    15 hours ago

    Ballerup, Denmark GN Store Nord AS Full time

    As an IC Tool Flow Specialist, you will contribute to our purpose of Bringing People Closer. You will manage and develop our IC tool flow for both frontend and backend, ensuring that our IC flows are productive and scalable. By working closely with our team of highly skilled ASIC design and verification engineers, you will take our tool flow to the next...

  • IC Tool Flow Specialist

    2 days ago

    Ballerup, Denmark GN Group Full time

    As an IC Tool Flow Specialist, you will contribute to our purpose of Bringing People Closer. You will manage and develop our IC tool flow for both frontend and backend, ensuring that our IC flows are productive and scalable. By working closely with our team of highly skilled ASIC design and verification engineers, you will take our tool flow to the next...

  • IC Tool Flow Specialist

    23 hours ago

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

    As an IC Tool Flow Specialist, you will contribute to our purpose of Bringing People Closer. You will manage and develop our IC tool flow for both frontend and backend, ensuring that our IC flows are productive and scalable. By working closely with our team of highly skilled ASIC design and verification engineers, you will take our tool flow to the next...

  • Student worker

    1 week ago

    Ballerup, Denmark Bosch Full time

    Job Description Join our Intelligent Process Automation team and be part of revolutionizing our business processes. Don't miss this opportunity to accelerate your career and contribute to our journey of innovation! We're seeking a student worker to support our Europe North organization in leveraging automation technologies for efficiency and innovation....

  • Student worker

    1 week ago

    Ballerup, Denmark Rexroth Full time

    Job DescriptionJoin our Intelligent Process Automation team and be part of revolutionizing our business processes. Don't miss this opportunity to accelerate your career and contribute to our journey of innovation!We're seeking a student worker to support our Europe North organization in leveraging automation technologies for efficiency and innovation. In...

  • Quality System Specialist

    1 week ago

    Ballerup, Denmark Ambu AS Full time

    Country: DenmarkLocation: Ballerup, DKCity: BallerupBusiness Area: QA/RAEmployment type: Full-timeDo you have a QMS simplicity mindset? Do you thrive in driving business priorities, juggling several balls at once? Do you have a passion for quality and great team work?Then this might be your defining moment. Apply today and join us for a career...

  • Quality System Specialist

    1 week ago

    Ballerup, Ballerup Kommune, Denmark Ambu AS Full time

    Country: DenmarkLocation: Ballerup, DKCity: BallerupBusiness Area: QA/RAEmployment type: Full-timeDo you have a QMS simplicity mindset? Do you thrive in driving business priorities, juggling several balls at once? Do you have a passion for quality and great team work?Then this might be your defining moment. Apply today and join us for a career...

  • ASIC Design Engineer

    4 weeks ago

    Ballerup, Denmark GN Group Full time

    As an ASIC Design Engineer - IC Tool Flow Specialist, you will contribute to our purpose of Bringing People Closer. You will manage and develop our IC tool flow for both frontend and backend, ensuring that our IC flows are productive and scalable. By working closely with our team of highly skilled ASIC design and verification engineers, you will take our...

  • Regional Portfolio Specialist

    4 weeks ago

    Ballerup, Denmark Bosch Full time

    Job Description Department: Power Tools The Regional Portfolio Specialist with focus on Product Demand collects all critical market insights for specific trades and product segments in the region EA. This function is a key interface for the Global Portfolio Management team to understand and prioritize regional product demand. Gathers deep knowledge...