At MiniMed, you can begin a lifelong career of exploration and innovation, while helping make a difference in the lives of people living with diabetes around the globe. You'll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world.
We are seeking an experienced Quality Director to provide strategic quality leadership for our operations in Ireland. This is a senior, site-facing role responsible for strengthening quality systems, maintaining inspection readiness and ensuring that quality and patient safety risks are identified, communicated and resolved effectively. This is a 12 month fixed term contract.
The successful candidate will bring extensive leadership experience within the medical device industry, ideally gained across multiple sites and a broad range of product technologies. They will combine strong technical expertise with the ability to influence senior stakeholders, lead through complex quality challenges and foster a culture in which quality and patient safety are embedded throughout the organisation.
Provide strategic and operational leadership for the Quality function, ensuring alignment with MiniMed’s business objectives and global quality strategy.
Lead, develop and support quality teams across one or more medical device sites.
Ensure compliance with ISO 13485, FDA Quality System requirements and other applicable global medical device regulations.
Maintain a high level of inspection readiness and lead both front-room and back-room activities during FDA inspections and other regulatory or notified-body audits.
Provide quality leadership for the introduction and commercialisation of new products, ensuring appropriate quality planning, risk management and design-transfer controls.
Establish, maintain and continuously improve critical Quality Management System elements, including:
Provide quality oversight across a range of technologies, including capital equipment, disposable products and other non-capital medical devices.
Identify, assess and escalate significant quality, compliance and patient safety risks, ensuring timely investigation and effective resolution.
Partner with Operations, Manufacturing, Engineering, Regulatory Affairs, R&D and other functions to address complex quality issues and support business objectives.
Champion initiatives that strengthen quality culture, accountability and employee engagement across the organisation.
Use quality data and performance indicators to identify trends, prioritise improvement opportunities and support effective decision-making.
Represent the Quality function with senior leaders, regulators, notified bodies and other external stakeholders.
Extensive senior leadership experience within Quality, ideally including 20 or more years in the medical device or another highly regulated industry.
Demonstrated experience leading quality functions across multiple sites or within a complex international organisation.
Expert knowledge of ISO 13485, FDA regulations and medical device Quality Management Systems.
Significant experience leading regulatory inspections, including responsibility for front-room and back-room inspection activities.
Proven experience supporting new product introductions and establishing robust quality systems and processes.
Broad product experience encompassing capital equipment, disposable products and non-capital medical devices.
Strong understanding of CAPA, complaint handling, management review, quality risk management and other core QMS processes.
Demonstrated ability to identify, communicate, escalate and resolve significant quality and patient safety risks.
Experience leading quality culture and continuous-improvement initiatives within medical device manufacturing environments.
Strong people leadership, stakeholder management and executive communication skills.
Bachelor’s degree in Engineering, Science, Quality or a related discipline; an advanced degree is advantageous.
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
MiniMed offers a competitive salary and flexible benefits package
At MiniMed, we put people first. A commitment to our employees lives at the core of our values: We recognize their contributions. They share in the success they help create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life.
We want to make every day a better day for people living with diabetes. Our team of creative innovators around the globe share a passion for finding the simplest solutions to the problems that people with diabetes face on a daily basis. For more than 40 years, we've been redefining what's possible, from intelligent dosing systems designed for real life to predictive insights that stay a step ahead, and we're dedicated to continuing to support our customers through every step of their journey — meeting them where and how they need it.
