Role Overview
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This position focuses on driving continuous improvement initiatives and ensuring the integration of Quality Management Systems (QMS). The ideal candidate will have expertise in process development, Lean/Six Sigma methodologies, and a solid understanding of regulatory requirements.
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Main Responsibilities:
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* Analyzing processes to identify areas for improvement and implementing data-driven solutions
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* Developing and maintaining QMS procedures, standards, and policies
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* Collaborating with cross-functional teams to streamline business processes and ensure regulatory compliance
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* Identifying training needs and providing support to enhance employee knowledge and skills
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Requirements:
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To succeed in this role, you will need:
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* A Bachelor's degree in a scientific, engineering, or related field
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* At least 5 years of experience in process development, preferably in the medical device or pharmaceutical industries
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* Knowledge of ISO quality requirements (9001/13485) and applicable Quality System Regulations
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* Strong communication and project management skills, with the ability to manage complex projects and stakeholders
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* Familiarity with tools like Visio, Word, PowerPoint, and Excel
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Benefits:
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We offer a comprehensive training program to support your growth and development, as well as opportunities for continued learning and professional growth. Our team is committed to making Hologic a great place to work, where top talent can thrive.