Carrigtwohill, IRL
2 days ago
Senior Quality Engineer - Product Transfer (fixed-term contract)
Within the **QA Shared Services – Product Transfer** team, you will play a key role in the successful execution of **global manufacturing transfers** . You will ensure regulatory compliance, support validation activities, and contribute to continuous improvement initiatives to deliver efficient transfers in terms of **quality, cost, and timelines** . This is a 1-year fixed-term contract as part of a maternity leave replacement, with the possibility of extension. **Key Responsibilities** **Support all types of manufacturing transfers** **, including supplier-to-supplier, supplier-to-Stryker, Stryker-to-supplier, and inter-site Stryker transfers** + Review and approve **validation and qualification documentation** + Act as the **Quality Assurance point of contact** during scope definition, planning, and execution of supplier transfers + Provide quality guidance related to applicable **regulations, standards, and procedures** + Identify potential **quality risks** during transfers and propose effective mitigation solutions + Collaborate with multiple divisions (T&E, Joint Replacement, Endoscopy) and contribute to **quality best practices** across the organization **Candidate Profile** **Required Qualifications** + University degree in **Engineering, Science or a related field** + Minimum **2 years of experience** in Quality Assurance and validation, preferably in the **medical device or pharmaceutical industry** + Strong knowledge of **quality concepts, risk management tools, and regulatory standards** (ISO 13485, FDA 21 CFR Part 820) + **Fluent in English** **Preferred Qualifications** + Experience with **Quality Management Systems (QMS)** or **Supplier Quality** + Excellent **communication, presentation, and project management skills** , with strong attention to detail + **Lean Six Sigma certification** (ideally Green Belt) Join an international and regulated environment, at the heart of high-impact quality transfer projects, contributing directly to the improvement of healthcare. Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
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