KARL STORZ GmbH & Co. KG, is an international leader for more than 70 years in endoscope technology, encompassing all endoscopic specialties. KARL STORZ designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship and clinical effectiveness. Headquartered in El Segundo, California, KARL STORZ Endoscopy-America, (KSEA) is responsible for all U.S. distribution of endoscopes, sterile single-use devices, instruments, imaging systems, electromechanical devices and OR1® integration technologies.
Quality System Engineer is responsible for driving continuous process improvement in the KARL STORZ America Quality Systems. This includes supporting and executing strategies for maintaining the global Quality Systems according to FDA and ISO 13485 requirements. Collaboration is essential for this position with process owners and functioning as a project manager to drive QS improvement projects and implement best practices to ensure effectiveness of the global quality process. The Quality System Engineer needs to proactively monitor global initiatives that impact and support effective quality planning. This position reports directly to the Director of Quality, North America.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Provide direction and support for multiple company locations adopting changes to the global Quality System framework.
Manage projects for QS CAPA in North America.
Ensure alignment with corporate standards and cGMP guidelines as well as assisting in increasing reported quality metrics.
Provide coaching and mentoring to global process owners through effective support of QMS.
Collaborate with management from all sites to facilitate and ensure company practices are consistent and compliant.
Facilitate meetings to engage global leadership on Quality System framework and initiatives.
Create, maintain and utilize a “Standard Work” approach to perform tasks and produce deliverables needed to support teams, develop solutions and manage projects.
Manage cross-functional teams to meet project plans including timelines and budgets.
Support Quality metrics: Collect, maintain, trend, and analyze data.
Collaborate across the organization at all functional levels and locations.
Implement and Utilize tools to drive compliant and effective processes.
Set short term and long term goals for continuous improvements (e.g., using Value Stream Mapping) to reduce costs, eliminate waste and improve processes to achieve product quality, customer satisfaction, and other key performance indicators.
Provide interpretations and training as needed
A Bachelor’s degree, preferably in areas engineering or science.
Certificates in quality would be a plus (e.g. CQM, CQE, CQA)
Project Management desired
DESIRED SKILLS AND EXPERIENCE:
Subject matter expertise in Quality Systems for medical devices.
Demonstrated knowledge and understanding of regulations and guidelines governing the areas of medical device development and manufacturing.
Ability to organize complex information into meaningful structures appropriate for diverse audiences.
Possess a broad knowledge of functional areas impacted by Quality Systems.
Demonstrated track record of systematically improving global Quality Systems.
Experience in leading cross functional teams.
Project management skills, including: set priorities, analyze risks, and make appropriate judgments and decisions.
Excellent written and verbal communication skills.
Ability to work individually with minimal supervision and as part of team.
KARL STORZ Endoscopy-America, Inc. (KSEA), is an affiliate of KARL STORZ GmbH & Co. KG, an international leader for more than 70 years in reusable endoscope technology, encompassing all endoscopic specialties. Based in Tuttlingen, Germany, KARL STORZ GmbH & Co. KG is a family-owned company that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, pre...cision craftsmanship and clinical effectiveness. Headquartered in El Segundo, California, KSEA is responsible for all U.S. distribution of endoscopes, instruments, imaging systems, electromechanical devices and OR1® integration technologies.