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 Systems Project Manager.
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.
As a Quality
Systems Project Manager, you will participate in the management, governance,
and execution of Quality Management sub-systems. Specifically, you will be
required to interact and collaborate with cross-functional teams to promote and
drive Quality Systems compliance regarding training, internal/external
auditing, and CAPA. Additionally, this role will lead specific quality
improvement projects as required to support QT and other business initiatives. You
will be expected to apply problem solving and interpersonal skills and be able
to influence and drive results.
- Manage the POC CAPA program within the Edgewater location.
- Manage the Internal and External Audit processes, which will include the harmonization of these process across POC.
- Support the development, monitoring and reporting of Quality Systems key performance indicators (KPIs), which will include assisting in the development of Quality Goals & Objectives across POC.
- Support the Document Control and Training functions.
- Analyze complex production and quality trend data to identify and solve problems.
- Design and develop systems for recording, evaluating, and reporting quality data.
- Perform economic implication analyses, prepare reports of findings and carry out complicated implementation and training assignments.
- Conduct complex audits and/or surveys to determine acceptability of quality controls.
Required Experience, Skills and Qualifications
- Bachelor’s degree in a related discipline or equivalent combination of education and experience. Discipline in Engineering, Biochemistry or Chemistry or other technical field preferred.
- Prefer candidates that possess internal auditor certification (CQA) from ASQ or equivalent training in IVD / biomedical industry.
- 5-8 years of experience in a Quality role within an FDA regulated industry preferably medical device and diagnostics that includes experience with CAPA and auditing processes.
- ASQ certifications such as CQA, Six Sigma, CQE, CQT or equivalent are highly desirable.
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.
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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