Temp Quality Engineer (18 month contract)

Medtronic - Athlone, County Westmeath (30+ days ago)

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Together, we will change healthcare worldwide. Join us in our Mission to alleviate pain, restore health and extend life worldwide. Let’s work together to address the universal healthcare needs and improve patients’ lives, optimize costs and efficiencies, and expand global access. Together, we can make a real difference in the global disparity in care. By providing quality care at the lowest possible cost, we will succeed as a company, and take the future of healthcare Further, Together.

At our Projects Engineering Department in Medtronic Athlone we focus on providing stable, flexible and cost effective solutions to enhance our processes and systems that produce the highest quality products through the deployment of innovative engineering projects and solutions. Quality Engineers are directly involved in understanding and providing compliance solutions and documentation throughout the project lifecycle, designed to continuously improve our manufacturing processes, systems, quality and regulatory compliance to the highest standards.

You will be a key contributor and team player in the provision of Quality assurance and compliance to engineering projects and services. You will plan and execute validation IQ, OQ & PQ protocols and reports to FDA requirements. You will co-ordinate the completion of risk management, process capability and statistical assessments and will provide quality engineering support to resolve process problems. You will write, review and update compliance documents, procedures, protocols, reports and relevant documents required in the course of achieving Quality compliance. You will develop and maintain a deep understanding of processes and products within areas of responsibility in order to support process improvements, changes and projects. You will support non-conforming investigations using robust root-cause analyses tools. You will liaise with cross functional teams, utilizing influencing skills where appropriate, to achieve assignments on time. You will establish and develop strong and effective working relationships at all levels to ensure maximum effectiveness.
We are looking for a qualified person to third level degree in a relevant Quality/Engineering/Science related discipline and preferably with 4-6 years relevant experience in a medical devices or similar regulated environment. You are a results driven and dynamic team player and can work effectively and proactively on cross-functional teams. You are knowledgeable in Quality Systems, validation standards, policies, procedures and methodologies. Knowledge, understanding and implementation of GAMP5 is an advantage. You are experienced with practical working knowledge of statistical data analysis and quality improvement tools and techniques. You must think critically and make sound decisions. You must be focused on patient and customer and set high standards, instill operational excellence, and drive accountability. You have excellent written, documentation, and oral communication skills and are fluent in English, both written and spoken. You have excellent organizational skills and have the ability to prioritize and work effectively on multiple projects.

Leadership Expectations provide the framework for what we expect from all employees at Medtronic – outlining the actions and behaviors we must develop and demonstrate in pursuit of our Mission and global growth goals.

We are committed to being experts in what we do, with a clear vision of where we are going and the plan to get there.
• Demonstrates Global Business Acumen
• Thinks Critically and Makes Sound Decisions
• Sets Strategic Direction
We partner with and involve others, knowing that diverse talent, skills, and perspectives lead to better outcomes.
• Collaborates and Creates Alignment
• Attracts, Deploys, and Develops Talent
• Fosters Diversity and Inclusion
We are bold thinkers who create new ideas and bring our best solutions forward to benefit our patients, partners, and customers.
• Focuses on Patient and Customer
• Generates Breakthrough Ideas
• Initiates and Leads Change
We do what we say we are going to do, delivering results with the highest standards.
• Sets High Standards
• Instils Operational Excellence
• Drives Accountability
• Models Ethical Behavior