Director Design Quality Assurance

Description:

This is a chance to step into a new position strategically leading the global product development QA department (double-layer management) in a well-established global player. As a leader for a team of 12 (including a team manager), you will also be responsible for driving the strategy and a high standard of quality across all business units and products portfolios including medical device, software and pharmaceuticals. To keep in touch with the technical elements, you will oversee the whole life cycle end-to-end and ensure that all the necessary deliverables are met within your team.

You can expect this function to have a lot of collaboration with key process owners across R&D and other quality teams to make improvements to the relevant processes, increasing their efficiency. This position has patient safety at its core so if you are passionate about improving patients' lives this is a great opportunity to have a true impact on them as well as the customer and organisation.

🔸 As Global Director you will (not an exhaustive list):

• Strategically lead team members and develop their skills professionally across all activities within Quality Assurance for the product development lifecycle
• Be a part of the QA leadership team and carry out activities based on decisions by the boards and Steering Committee
• Ensure the QMS for product development and lifecycle management is compliant, efficient and agile with specific focus on Design Control, Change Control, Risk Management, usability and other related processes
• Author, review and approve quality system documentation i.e. policies, procedures, work instructions
• Review process internally and where necessary simplify them to drive continuous improvement
• Provide strategic guidance for product development and change control throughout the product lifecycle across all business units
• Interpret regulatory/quality requirements within the product development and life cycle management processes including Design Control, Change Control, Risk Management, Usability for engineering and other related processes
• Provide support and training for applicable functions and roles on processes throughout the product development lifecycle
• Represent the business for auditors and inspectors as appropriate and ensure audit readiness
• Feedback relevant data analytics and statistics to senior management

🔹 Your qualifications:

• Minimum 10 years of experience in Quality or R&D for medical devices with a deep knowledge of design quality processes
• Experience with embedded of standalone software medical devices (IEC 62304)
• Eligibility to live and work in Europe