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 60,000 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 Global Audit Manager
This is a role well suited to an ambitious professional, looking for the next step in their career. As a Global Quality Audit Manager, you will be responsible for:
- Planning, Management, and Execution of the Global Audit Program.
- All activities required to plan, prepare for, conduct, report and close the assigned audits.
- Ensuing a proactive determination of regulatory, compliance and quality issues and integrate them into audits/assessments on a priority basis.
- Communication and documentation of internal and external compliance related information. Includes changes in regulations, new guidelines and guidance documents from regulatory authorities and trade organizations.
- Leading continuous improvement initiatives including creation, scoping and implementation.
- Managing assigned global quality projects and compliance initiatives.
- Driving interactions with other locations and organizations/functional groups to ensure consistency in application of Quality Compliance strategy and to promote standardization of auditing approach within Quality.
This position may suit you best if you are familiar with what is below, and would like to do develop your career with Siemens-Healthineers Ultrasound business:
- Excellent understanding and practical application of global medical device standards and regulations, in particular ISO 13485, 21CFR820, CMDR, MDR, ANVIA, TGA.
- General knowledge of technical and medical device processes, validation procedures and analytical methodology.
- Understanding and overcoming different cultural and language obstacles to provide solution that satisfy, corporate, regional, and local objectives.
- Analyzing data to support the development of strategies to effectively manage the action plans that will resolve the issues.
Required skills to have for the success of this role
- Bachelor’s Degree in chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/scientific area.
- At least 10 years in the Medical Device Industry and/or Government Regulatory Agency; and at least 5 years of Medical Device Auditing experience, with a minimum of 3 years as lead auditor, leading audits related to GMP, GDP or ISO for Pharmaceuticals or Medical Devices.
- Must be capable of assessing compliance requirements using sound judgement and decision-making skills.
- Excellent oral and written communication, collaboration, and interpersonal skills with the ability to influence others, facilitate team interactions, and partner with key stakeholders
- Excellent project management skills.
- Ability to work with ambiguity and adapt plan when needed.
- Demonstrated ability to coach and provide feedback.
- Ability to work collaboratively to achieve objectives.
- Excellent problem-solving skills.
- ISO 13485 Lead Auditor or ASQ Certified Auditor, preferred.
- Ability to work with minimum supervision.
- Innovative with the ability to make sound suggestions for improvement.
- Travel may be up to 15% of this position.
Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity. Going forward, please be aware that Siemens Healthineers requires full COVID-19 vaccination for all new hires by their start date except where prohibited by state law.
(Note: Accommodations may be requested for certain medical or religious reasons)
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 Medical Solutions USA, Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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