Siemens Healthineers Senior Manager Quality Systems in Norwood, Massachusetts
The Senior Manager, Quality Systems will be responsible for the governance, and execution of the Quality Management System at the Norwood, Ma (Edgewater) facility within the Point of Care (POC) business. Specifically, you will maintain and oversee all aspects of the Quality Management System. This includes responsibility for the Quality Systems team of Engineers, ownership/oversight of CAPA, document control, internal and external audit, non-conformance, product-related environmental protection (PREP), supplier quality and training processes, as well as overall audit readiness. The Senior Manager is expected to drive quality Key Performance Indicators (KPI) metrics and report results to management.
Additionally, this role will lead and/or oversee specific quality improvement projects, as required, to support QT and other business initiatives including, but not limited to, leading Edgewater site external audits, managing the POC internal audit program, leading the POC TRSM program, and driving change within the POC QMS. The individual in this role is expected to act as a change agent, apply advanced problem-solving techniques and interpersonal skills and be able to influence and drive results.
Lead external audits forEdgewater facility, including execution of audit readiness activities andcoordination of audit logistics with SMEs
Provide strategicoversight of all QMS processes and initiate changes, as applicable
Lead the POC wide internalaudit program
Lead the POC wide TRSMprogram
Support the development,monitoring and reporting of key performance indicators (KPIs), which willinclude assisting in the development of Quality Goals & Objectivesacross POC
· Experience with managing complex issues with potential for significant business impact
· Exceptional attention to detail with strong organizational and technical skills
· Advanced knowledge of FDA regulations, EU IVD Directive and new IVD regulations, pertaining to Quality System regulation (e.g. ISO 13485:2016)
· Strong leadership skills
· Experience in lean methods like Six Sigma, Agile or Business Systems for operational excellence
· Strong analytical skills and data driven mindset
· Must manage multiple projects simultaneously
· Must have strong written and verbal communication skills, including presentations to senior management
· Key leader during site audits including direct interface with investigators
Required Knowledge/Skills, Education, and Experience
BS/BA in related discipline, or advanced degree (preferred), or equivalent combination of education and experience
Minimum of 10 years of successful management experience in Quality field. Experience with FDA Quality System Regulations and audits.
Travel may be up to 10% for this position
Preferred Knowledge/Skills, Education, andExperience
Additional expertise in Quality Systems and/or Quality Assurance is a plus as this role is a high-ranking position within the QT team at POC.
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.
“Successful candidate must be able to work with controlled technology in accordance with US export control law.” “It is Siemens Healthineers’ policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.”
As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.
If you want to join us in transforming theway 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 .
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