Continuous Improvement and QMS Integration Project Lead

As a leading innovator of women's health, we at Hologic are 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. As our Continuous Improvement and QMS Project Lead, you will be responsible for writing and implementing procedure for EMEA – data gathering and analysis, best practice research, process mapping, developing and recommending alternatives for improvement, developing performance metrics, implementing improvements, and monitoring post-process improvement initiative performance to updated KPI's. Your expertise will allow you to provide business process solutions to meet internal and external customer expectations, including regulatory compliance. Your Lean/Six Sigma background will enable you to partner with key stakeholders and execute strong results. What to expect: Data GAP Analysis: Identify sources for gathering and analyzing data relevant to processes. Define requirements for data and set standards of data collection. Research: Review quality documents, quality standards (ISO 13485:2016) and best practices. Make recommendations on appropriate solutions based on research. Process Architecture: Influence stakeholders and process owners to define processes and identify interactions with cross functional processes, define standards and methods. Design process blueprint. Process Recommendations: Independently initiate, identify and coordinate the analysis of complex internal client needs in project areas in various business operating models including direct and indirect markets. Harmonization and streamlining of cross divisional business activities ongoing projects. Negotiate: Mediate all final requirements with key stakeholders. Apply Lean/Six Sigma concepts and techniques to process improvement initiatives. Share accountability for realization of results with process owners and will present recommendations to stakeholders and process owners. Performance Management & Control: Define, develop and evaluate performance metrics to establish process success, including working with multiple stakeholders, often with competing/conflicting objectives, to ensure cohesive and reachable measures of success. Change Management: Lead in change management activities for highly complex initiatives. Champion process improvement culture. Lead the process development transition from project to operations to ensure a smooth and successful transition What We Expect: BS or equivalent in scientific, engineering, or related discipline Knowledge and abilities that are typically acquired through 5 years' experience in process development in the medical device or pharmaceutical industries. Proficient in the knowledge of applicable Quality System Regulations and ISO quality requirements (9001 / 13485) Advanced knowledge of supplier chain, customer service, and quality assurance requirements Project management expertise, experience in Lean/Six Sigma Expertise to exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions Strong communication skills, for example to ensure succinct report generation, effective communication with staff, peer groups, etc. across organisation Ability to manage complex projects with different stakeholders / departments Knowledge of VISIO, Word, PowerPoint and Excel, with the ability to provide reports Why Hologic? We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to ena... Expertise, Pharmaceuticals, Customer Service, Report Development, PowerPoint, Business, Operating Models, Quality systems, Research, ISO13485, Management control, Projects, Quality assurance, Regulation, Process Development, Process Development, Policy, Coordination, Engineering, VOS, Metric, Quality Control, Visio, Best Practices, Communication, Blueprint, Gap Analysis, Design, MS Excel, Operations, ISO Quality, Dataset, Analysis, Negotiation, Accountability, Management, Lean Six Sigma, Project Management, Medical Devices, Architecture, Change Management, Data acquisition, Science Originele vacature is te vinden op StepStone.be – Maak nu een Jobagent aan op StepStone en vind je droombaan! https://bit.ly/2jPYsZC Vind gelijkaardige jobs, informatie over werkgevers en carrièretips op StepStone.be! 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