Innovation Process Specialist

2 weeks ago

Penang, Malaysia Ambu Full time

Business Area: R&D- Employment type: Full-timeDo 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?

**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

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.

**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.

**About Ambu**:
Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.

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