• Staff Chemist Limerick
  • Stryker in Limerick, , Ireland
  • jobs
  • 4 weeks ago

jobs description

Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World's Best Workplaces, apply now !

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

Who we want:
• Patient-oriented achievers. Engineers with an unparalleled work ethic and customer-focused attitude who bring value to their partners
• Collaborative Partners. Relationship-savvy people who intentionally make connections, listen to others' ideas and work together to move the business forward.
• Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will... stop at nothing to ensure a project is complete and meets regulations and expectations

What you will do:

Will work within the chemistry team, under minimal supervision, with responsibility to ensure effective and efficient chemistry & laboratory practices, which include, but not limited to the following:
• Provide expert chemistry technical input to the manufacturing and analytical testing functions, acting as champion for implementation of industry best practice, standards and regulations in chemistry and related areas
• Provide innovative, quality focussed technical input and solutions into NC/CAPA resolution. Deliver Technical Assessments to support SofHA rationale.
• Assess cost-saving opportunities, provide innovative solutions for business while maintaining focus on compliance, ensuring implementation of industry best practice and new technology.
• Participate/ Lead in cross functional / site project/investigation teams as required and have ability to successfully communicate complex technical content.
• Design and provide technical training and education for the business as required, in areas of expertise. Mentors and trains team and cross functional groups as required.
• Subject matter expert to internal & external regulatory requirements, (including but not limited to European RHQ, Division, Corporate, FDA, ISO, MDD, and individual country regulatory requirements)
• Calloborate with the global Stryker team where applicable in providing innovative consolidation solutions. Participate in relevant forums/conferences.
• Support as needed in all regulatory audit preparation.
• Subject matter expert to local procedures, contribute to the development, maintenance and improvements of the policies and procedures to align to best practices, benchmarking against industry leads and regulatory requirements.
• Support of, ensure compliance of new products to sites' chemistry standards. Ensure successful integration of products into validated processes.
• Demonstrate technical supervisiory capabilities and leads projects to completion
• Demonstrates knowledge of the business processes and products across multiples sites.
• Deputises for the Chemistry Laboratory Team Leader / Associate Manager in their absence.

What you will need:
• Bachelor degree/ Masters Chemistry or related subject or equivalent
• and
• 4 years chemistry related experience.
• Minimum of 5 years in regulated environment.
• Advanced knowledge and understanding of US and International Medical Device Regulations and standards in area of expertise (Chemistry)
• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required.
• Strong analytical skills in both Inorganic and Organic chemistry.
• Experience in working in a compliance risk situation.
• High proficiency in statistical techniques, data review and analysis.
• High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages
• Some travel may be required.

About Stryker
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 130 million patients annually. More information is available at stryker.com
Limerick Ireland


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