Join us to apply for the Senior Quality Assurance Professional role at Siemens Healthineers.
About the role
We are seeking a Senior Quality Assurance Professional to join our team at our facility in Swords, Co. Dublin. In this role, you will be part of an innovative production and quality network focused on delivering high-quality products for laboratories of any size, today and in the future.
Your responsibilities include:
1. Acting as a key liaison among Supplier Quality, Quality Assurance, Manufacturing Engineering, R&D, Production, and Documentation Control.
2. Assessing suppliers’ capabilities to meet quality requirements through data analysis and audits, and creating reports to facilitate improvements.
3. Using statistical analysis to support suppliers and enhance regulatory standards, developing supply chain processes suitable for a high-complexity environment.
4. Collaborating with suppliers on quality areas such as First Articles, regulatory requirements, Corrective & Preventive Actions, Root Cause Investigations, and performance reviews.
Qualifications and experience:
1. Proven experience in Medical Devices QMS, especially in low volume, high complexity environments.
2. Experience managing supplier projects and improving processes.
3. Bachelor’s degree in a relevant technical discipline, with at least 8 years’ experience in a regulated environment familiar with FDA regulations and Risk Management.
Skills and attributes:
1. Strong leadership, collaboration, and communication skills.
2. Ability to influence cross-functional teams and develop standard operating procedures.
3. Proficiency with statistical tools (e.g., Minitab), MS Office, and ERP systems like SAP.
4. Understanding of diagnostic technologies such as Immunology, Biochemistry, and Hematology is advantageous.
About Siemens Healthineers
We are a global team of over 70,000 employees dedicated to advancing healthcare. Our culture promotes inclusivity, innovation, and continuous improvement, aiming to make a positive impact on patient outcomes worldwide.
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