Quality Systems Engineer - United States
KARL Storz (company)
KARL STORZ Endoscopy-America is currently seeking to hire a Quality System Engineer.
The 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 with 10+ years of experience, preferably in areas of life sciences, engineering, or quality assurance.
- Certificates in quality would be a plus (e.g. CQM, CQE, CQA)
- Project Management Professional (PMP) certification or related project management credentials, 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.
KSEA provides equal employment opportunities (EEO) to all applicants without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, KSEA complies with applicable state and local laws governing non-discrimination in employment.