Product Quality Manager

Warwick

Hybrid working (potential to be home based for the right candidate)

As Product Quality Manager you’ll play a pivotal role in the oversight and optimisation of Quality Management activities for the Quanta product portfolio. The Product Quality Manager focuses on strengthening existing quality systems, enhancing process adherence, and identifying opportunities for process improvements. The primary objective is to ensure the ongoing safety, quality, and compliance of Quanta products within the framework of established quality systems.

Working collaboratively with the Quality Systems Manager and other departmental managers, this position ensures seamless alignment between quality plans, systems, and processes, promoting cohesion and synergy across the organisation. The Product Quality Manager is committed to maintaining the highest safety standards for Quanta products and upholding strict compliance with all Quality System requirements and regulations.

Quanta Dialysis Technologies is on a mission to make dialysis accessible to every patient in every setting with its innovative SC+ system. With its compact size, intuitive design and GUI interface, and proven performance, SC+ offers a portable solution that delivers powerful clinical outcomes.

SC+ is commercially available in the UK for home and hospital use and is FDA cleared for use in chronic and acute care settings.

As the preferred candidate for the role of Product Quality Manager, you’ll have:

• Experience in Quality Assurance and Regulatory Affairs (QARA) teams within medical device companies focused on medical device product quality.
• Proven leadership experience running product quality assurance teams.
• Proven experience working with Programmable Electrical Medical Systems (PEMS) or equivalent high-integrity software-intensive systems, involving complex devices requiring multidisciplinary development efforts (mechanical, software, electronics, system integration, pneumatics, fluid mechanics, etc.).
• Strong experience and capability in root cause analysis, leading issue investigations and resolutions, and proficiency in documentation and testing.

In return we offer:

• Competitive base salaries dependant on experience
• Company bonus scheme
• Contributory Pension
• Life Assurance
• Income Protection
• Perkbox

If you meet the criteria for Product Quality Manager and would like to be part of our journey, apply with a CV now. Your next career move could be just around the corner!