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Quality Management System (QMS) Specialist

Job Description

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 Quality Management Specialist (QMS).

 

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

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

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

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.
  • 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 3 years in the Medical Device Industry and/or Government Regulatory Agency
  • 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
  • General project management skills.
  • Ability to work with ambiguity and adapt plan when needed.
  • Ability to work collaboratively to achieve objectives.
  • Good problem-solving skills.
  • Ability to work with minimum supervision.
  • Innovative with the ability to make sound suggestions for improvement.
  • Travel may be up to 5% 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.  Accommodations may be requested for certain medical or religious reasons.  If you choose to submit an accommodation request it should be submitted within 3 business days of receiving a verbal offer.  Details on how to submit approval will be provided by your recruiter.  An accommodation approval must be confirmed prior to your start date.  A start date cannot be confirmed until the accommodation has been reviewed.  An accommodation is based on your role.  If you are a currently a Siemens Healthineers employee with an existing approved accommodation, it will need to be re-evaluated prior to starting a new role.

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.

Beware of Job Scams

Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers Career Site.  

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.

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Organization: Siemens Healthineers

Company: Siemens Medical Solutions USA, Inc.

Experience Level: Experienced Professional

Job Type: Full-time



Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

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