Senior Product Compliance Specialist

3 weeks ago


Ireland Stryker Ireland Full time

Senior Product Compliance Specialist /Senior Product Field Action Specialist Who we want: Motivated product launchers.People who bring strategic direction and drive for execution to ensure products are developed and launched with precision. Self-directed innovators.People who take ownership of their work and need no prompting to drive productivity, change, and outcomes. Analytical problem solvers.People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues. Dedicated achievers.People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. Collaborative partners.People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions Whatyou'lldo: Conducted Product Field Action Assessments, including collaboration with subject matter experts and analyzing data to complete health hazard evaluations. Execute Product Field Actions, including communicating with consignees, health authorities, and notified bodies. Supports QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to Site, Division, Corporate, FDA, ISO, MDD, and individual country requirements). Support internal and external quality system audits. Engage in the development of optimum future state of QMS for business needs. Identify improvements and inputs into the quality planning process. Execute development and/or modification of Stryker's QMS. Support Management Review and Quality Planning Review and related forums. Assess and quantify requirements for QMS requirements to optimize structure. Support GMP and GDP within Quality organization. Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS. Support QMS training development and delivery. Contribute to the development, maintenance, and improvements of policies and procedures. Support implementation of best-in-class practices and benchmark against industry leaders and regulatory requirements. Support notified body communication. Ensure QMS reflects actual activities, business needs and supports NPD requirement. Basic project management understanding. Whatyou'llneed: BS in a science, engineering, business or related discipline. Minimum of 2 or more years' experience Skills: Product Field Specialist Quality Systems Engineering Compliance



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