Staff Quality Management System Analyst

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

We are looking for a Staff Quality Management System Analyst to join our site in Haifa (Israel) :

What you will do:

• Ensure 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).
• Develop optimum future state of QMS for business needs.
• Identify improvements and inputs into the quality planning process.
• Drive development and/or modification of Stryker's QMS.
• Manage and/or coordinate Management Review and Quality Planning Review and related forums.
• Assess and quantify requirements for QMS requirements to optimize structure.
• Drive GMP and GDP within Quality organization.
• Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS.
• Develop and deliver training for QMS areas of expertise.
• Contribute to the development, maintenance, and improvements of policies and procedures.
• Implement best-in-class practices and benchmark against industry leaders and regulatory requirements.
• Liaise and communicate with notified bodies to manage certification changes.
• Ensure QMS reflects actual activities, business needs and supports NPD requirements.
• Coordinate QMS activities to support achievement of project milestones.
• Provide direction for the overall QMS strategy. Lead improvement processes, executing and leading projects.
• Understand and contribute to the development and generation of IS compliance and validation documentation.
• Basic project management understanding.
• Owner of QMS business process(es) and understand IS system support requirements.
• Represent expertise during internal and external quality system audits.
• Strong knowledge of system integration.
• Assess and approve IS change control assessment and approval.
  
  

• BS in a science, engineering, business or related discipline.
• Minimum of 5 years experience in manufacturing environment (ideally in medical devices)
• Experience in regulated environment and interaction with regulatory agencies required.
• Thorough knowledge and understanding of US and International Medical Device Regulations.
• Strong knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.)
• Strong communication, project management and influencing skills.
• Ability to plan, organize, and implement multiple concurrent tasks.
• Analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions.
• Ability and versatility to manage changing priorities and workflow for multiple projects and deadlines
• Ability to interface with both technical and non-technical personnel at all organizational levels.