Design Quality Manager

Description:

The set-up of this position is quite unique to this business, it is an opportunity to be the change champion within the design and development part of the business and be responsible for ensuring quality compliance across all R&D activities in the four business areas. You will be responsible for identifying problems, devising and implementing solutions by influencing key stakeholders/teams and ensuring that all development activities across the business are harmonious and consistent. It’s not often that you have the opportunity to transform and influence quality in such a large, established organisation…

If you enjoy working as a team in a solution-oriented way, have a passion for quality and experience in design and development, this is just the position for you!

🔸 As Design Process Manager you will (not an exhaustive list):

• Author, review and maintain the quality system documentation (policies, procedures, working instructions) for the related QA/design processes
• Identify, interpret and evaluate new and existing regulatory and quality requirements to guide, advise and train the relevant teams to ensure compliance
• Anticipate compliance risks relating to the research and development processes and find solutions to mitigate the risks throughout the product lifecycle
• Implement the risk mitigation plan and train the stakeholders
• Drive continuous improvement through digitalisation
• Support audit and inspection readiness and activities related to the relevant processes
• Influence key stakeholders to make and implement changes to the relevant R&D processes
• Collaborate cross-functionally with all BAs to ensure an effective, harmonious and agile QMS
• Deliver continuous training and support for the design QA processes to relevant teams and stakeholders
• Establish the governance and the collaboration area (how to, with who etc.) between the process owner, BAs and other stakeholders to assure that the processes are fit for purpose today and future product portfolios

🔹 Your qualifications:

• Minimum 5 years of design quality assurance experience in the medical device industry
• Deep experience working with software medical devices
• Good understanding of design control/change control from concept to realisation of a product
• Eligibility to live and work in Europe