Senior Quality Director, Global Instrument Manufacturing
Now’s our time to inspire the future of healthcare together.
Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.
Join our team now at Siemens Healthineers as Senior Quality Director
This is a role well suited to an ambitious
professional, looking for the next step in their career. As a Senior Quality
Director, you will be responsible for:
- Developing, executing and leading global cross-site Quality strategies in alignment with instrument manufacturing objectives.
- Collaborates across sites and functions to sustain compliance to regulations, enhance product quality with focus on lean manufacturing, and digitalization.
- Drive adherence to quality Key Performance Indicators (KPI’s) metrics across sites and report results to management with focus on digitalization enhancements to aid in analysis.
- Propose preventative measures across sites, promote and implement improvement projects.
- Prepare sites and constantly sustain external audit readiness.
- Direct interface and lead to external audit bodies for on-site and virtual visits.
This position may suit you best if you are familiar
with what is below, and would like to do develop your career with
- Site quality head and quality management representative for Flanders NJ facility.
- Demonstrate and apply advanced Quality System expertise to address complex issues independently.
- Develop Cross-site goals in alignment with LD, LD Manufacturing and LD Global Quality priorities and targets to sustain compliance and enhance quality.
- Centrally manage and drive functional excellence to Siemens Healthcare Diagnostics.
- Drive data analytics and digitalization efforts of quality indicators.
- Collaborate and contribute with Global LD Qt staff and other site quality heads.
- Direct a team of quality professionals focusing on Quality Systems, Supplier Quality, Operational Quality, Quality Control and inspections, Design Transfer and Project Management.
- Support internal / external stakeholders to drive and improve instrument quality performance at the customer sites.
- Support day to day operational targets.
- Ensure overall site external audit readiness.
Required skills to have for the success of this role
- BS / BA in engineering or science discipline. Advanced degree preferred.
- 10 + years of successful experience in Quality Management field or Medical device regulated environments.
- Advanced knowledge of FDA regulations, EU IVD Directive, new EU IVD Regulations, ISO 13485, and MDSAP
- Strong leadership skills, leading teams of over 15 members.
- Six Sigma knowledge preferred.
- Experience establishing accredited quality management systems according to standards such as ISO 13485 and / or ISO 45001
- Experience with project management including management of QMS digital tools.
- Experience with budgeting process.
- Working understanding of Gage Dimensioning and Tolerancing (GD&T)
- Travel may be up to 20% for this position.
At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.
If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.
If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.
As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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