Quality Management System Specialist

Do you want to join us in helping to fight the world’s most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere.

We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting? Then come and join our global team as a Quality Management System (QMS) Specialist.

Our global team: We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.

Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers.

Join our team now at Siemens Healthineers as a Quality Management System (QMS) Specialist.

This is a role well suited to an ambitious professional, looking for the next step in their career. As a QMS Specialist, you will be responsible for:

• Planning, scheduling, and completing projects and activities with an aggressive sense of urgency manner consistent with corporate objectives.
• Supporting the efficient and effective execution of the Internal Audit Program, and other QMS subsystem elements as well as the support of external audits and inspections.
• Collecting, Analyzing, and Compiling data for various Quality Management processes, including Management Review.
• Performing other QMS support activities, as required.
• Partnering with cross-functional teams as required to ensure compliance with the Quality Management System.
• Developing and driving continuous improvement to quality system processes through the development, execution, monitoring, and reporting of Quality Plans.

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:

• General understanding and practical application of global medical device standards and regulations, in particular ISO 13485, 21CFR820, CMDR, MDR, ANVIA, TGA.
• Understanding and overcoming different cultural and language obstacles to provide solution that satisfy, corporate, regional, and local objectives.
• General knowledge of technical and medical device processes, validation procedures and analytical methodology.
• 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

• Good problem-solving skills.
• Must be capable of assessing compliance requirements using sound judgement and decision-making skills.
• Ability to work collaboratively to achieve objectives.
• Ability to work with ambiguity and adapt plan when needed.
• Excellent oral and written communication, collaboration, and interpersonal skills with the ability to influence others, facilitate team interactions, and partner with key stakeholders.
• Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/scientific area.
• Ability to work with minimum supervision.
• Innovative with the ability to make sound suggestions for improvement.
• General project management skills.
• Minimum 5 years in the Medical Device Industry and/or Government Regulatory Agency.

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.

The pay range for this position in Issaquah, WA is $97,000 - $112,000 annually; however, base pay offered may vary depending on job-related knowledge, skills, experience, and geographical location. The annual incentive target is 8% of base pay. Siemens Healthineers offers a variety of health and wellness benefits including paid time off and holiday pay. Details regarding our benefits can be found here: https://benefitsatshs.com/index.html

This information is provided per the required state Equal Pay Act. Base pay information is based on market location. Applicants should apply via Siemens Healthineers external or internal careers site.

As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.

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