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Why join Stryker?
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Job description
Senior Quality Engineer
Stryker is hiring a Senior Post-Market Intelligence Engineer for our Joint Replacement division in Anngrove, Cork. This role ensures compliance with FDA regulations by managing the timely closure of complaint records. It involves tracking and analyzing key process indicators to identify areas requiring improvement, conducting preliminary data collection and analysis for complaint investigations, and maintaining accurate records in investigation templates and the complaint database. The position supports management by providing actionable insights and ensuring adherence to regulatory requirements.
Work Flexibility: Hybrid.
What you will do:
- Work with all products, manufacturing and quality teams to determine root cause and to ensure proper corrective actions have been identified, implemented and verified to be effective.
- Participate in continuous improvement and process re-engineering projects in support of Stryker Orthopedics’ continuous improvement initiatives.
- Generate and analyze metrics and make recommendations as required to Quality Engineers.
- Generate data for Competent Authorities (FDA, BSI and other regulatory bodies).
- Collaborate with consulting clinicians on medical dictations.
- Mentor, oversee and approve the work of other Product Complaint Analysts and Product Complaint Representatives by providing technical training and coaching to colleagues.
What you need:
Required:
- Bachelor's Degree in Science, Engineering or related discipline
- Minimum 2 years’ experience working regulated environment
Preferred:
- Experience in Post-Market Surveillance
- Strong exposure to NC/CAPAs
- Previous experience in Medical Device Industry
- Experience and knowledge with regulatory requirements, such as ISO 9001 or ISO 13485, Quality System Regulation, and Medical Device Directive.
- Ideal candidate would possess one or more of the below certifications; CQE, CRE, Lean Six Sigma Green or Black belt.
- Experience and ability to manage complex or broad scope projects
- Experience in working within Microsoft Office software including Excel, Word and Power Point.
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 and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
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