About
As a leading innovator in women's health, Hologic is empowering people to live healthier lives everywhere, every day. Our quality and regulatory affairs teams are responsible for keeping abreast of new, changing, and existing regulatory requirements. They lead the development and implementation of a global vision for regulatory affairs, government relations, quality management, and market access, to influence strategic and operational plans.
We are seeking a Continuous Improvement and QMS Project Lead who will be responsible for writing and implementing procedures for EMEA, including data gathering and analysis, best practice research, process mapping, developing and recommending improvements, developing performance metrics, implementing improvements, and monitoring post-process initiatives to update KPIs. Your expertise will enable you to provide business process solutions to meet internal and external customer expectations, including regulatory compliance. Your Lean/Six Sigma background will be essential for partnering with stakeholders and achieving strong results.
What to expect
* Data GAP Analysis: Identify sources for data gathering and analysis, define requirements, and set standards.
* Research: Review quality documents, standards (ISO 13485:2016), and best practices; recommend solutions.
* Process Architecture: Influence stakeholders, define processes, identify interactions, and design process blueprints.
* Process Recommendations: Analyze complex needs, harmonize and streamline activities, and negotiate requirements with stakeholders.
* Performance Management & Control: Develop and evaluate success metrics, ensuring cohesive measures of success.
* Change Management: Lead change initiatives, champion process improvement culture, and oversee transition from project to operations.
What We Expect
* Bachelor's degree or equivalent in scientific, engineering, or related disciplines.
* At least 5 years' experience in process development within medical device or pharmaceutical industries.
* Knowledge of Quality System Regulations and ISO standards (9001 / 13485).
* Proficiency in supply chain, customer service, and quality assurance.
* Project management expertise with Lean/Six Sigma certification.
* Strong communication skills and ability to manage complex projects across departments.
* Knowledge of VISIO, Word, PowerPoint, and Excel.
Why Hologic?
We are committed to making Hologic the company where top talent comes to grow. We support your success and growth within our organization.
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