Quality CAPA Manager
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 Quality CAPA Manager.
This is a role well suited to an ambitious professional, looking for the next step in their career. As a Quality CAPA Manager, you will be responsible for:
- In your activities you will demonstrate Corrective and Preventive Action subject matter expertise and the ability to provide guidance in the areas of CAPA, change control, validation, design controls, design transfer activities, risk management, audit.
- You will Chair the CAPA Review Board for Glasgow Manufacturing CAPAs
- You will manage the site CAPA process and associated records
- You will track and trend CAPA information
- You will identify opportunities for improvement for both internal and external processes, lead continuous improvement initiatives, support problem solving of complex production issues, and report on quality trends
- You will independently perform full range of standard work as well as work collaboratively with cross functional team members across the organization
This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers
- You have in depth working knowledge and practical application of CAPA, change control, design controls, design transfer, risk management, audit, and statistical process controls
- You have in-depth knowledge of the requirements related to ISO 13485, FDA QSR, IVDR, and CGMP
- IVD reagents and consumables experience preferred
- You have proficient computer skills (MS Office Suite) and organizational skills
- You have proven the ability to work collaboratively with others helping them improve knowledge and documentation of CAPAs
- You have experience problem solving and working in a fast-paced manufacturing environment
- You demonstrate the ability to make decisions, prioritize, and communicate effectively across multiple levels
- You strive to continuously improve and are passionate about working in the Medical Device Industry
Required skills to have for the success of this role
- Bachelor’s degree in Engineering, Science, or equivalent experience required
- Minimum of 8-10 years of successful experience in the Medical Device Industry and Quality
- Certified Quality Engineer (CQE) or Six Sigma Certification preferred
- Willing to travel up to 20%
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: Mid-level Professional
Job Type: Full-time
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