QA Director - 12 month FTC

About the Role

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.

Key Responsibilities

• 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: Corrective and Preventive Action (CAPA) Complaint handling Management review Non-conformance management Change control Internal audits Quality risk management.
• Provide quality oversight across a range of technologies, including capital equipment, disposable products and other non capital medical devices.
• Identify, assess and resolve 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.

Required Experience and Qualifications

• 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, escalat ? 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.

Benefits & Compensation

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.

At MiniMed, 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. MiniMed is a full stack insulin delivery company dedicated to supporting people living with diabetes through every step of their journey - when and how they need it. With a heritage rooted in technology, empathy, and a relentless pursuit of innovation, we're focused on one thing: making every day a better day for people with diabetes. From our intelligent dosing systems that stay one step ahead to our always on support when it's needed most, we're committed to building a connected system of care that works together and fits into everyday life, so people with diabetes can move through the day with fewer interruptions. Fewer second guesses. And more freedom to live in the moment. We're here to make better days possible for people with diabetes. Joyful, messy, fully lived days. Days where things feel lighter, easier. For more than four decades, we've been driven by this mission, delivering groundbreaking advancements in technology to help people live more fully, freely, and with greater confidence. At MiniMed, diabetes care is personal for us. Many of our employees have a connection to diabetes, whether they're living with it themselves or through family members and friends, and we all show up each day to help make the lives of our coworkers and loved ones easier. Our people first priority. At MiniMed, we put our customers at the forefront of all we do, and that focus extends to our team as well. We're dedicated to creating a culture of belonging and providing our people with all the career building resources you might need. Our life transforming technologies. No matter what your role at our company, you're making a difference in the lives of people with diabetes. Our innovative inventions improve their day to day by helping lift the mental load and allowing diabetes to fade into the background, empowering them to live life on their own terms. Our focus on the future. We're chasing the dream of a world where people with diabetes can be free of that never ending battle of balancing blood sugar. A world where better days are the norm, not the exception. Fresh faces and new viewpoints will help create our cutting edge solutions and define the next generation of breakthroughs in care, so that a better day can start today.

It is the policy of MiniMed to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, MiniMed will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E Verify program to confirm the identity and employment authorization of all newly hired employees.