Offers “Siemens”

Expires soon Siemens

Senior Manager Quality Systems

  • Norwood, USA
  • Personal services

Job description

Position Overview

TheSenior Manager, Quality Systems willbe responsible for the governance, and execution of the Quality ManagementSystem at the Norwood, Ma (Edgewater) facility within the Point of Care (POC)business. Specifically, you will maintain and oversee all aspects of theQuality Management System. This includes responsibility for the Quality Systemsteam of Engineers, ownership/oversight of CAPA, document control, internal andexternal audit, non-conformance, product-related environmental protection(PREP), supplier quality and training processes, as well as overall auditreadiness. The Senior Manager is expected to drive qualityKey Performance Indicators (KPI) metrics and report results to management.

Additionally,this role will lead and/or oversee specific quality improvement projects, asrequired, to support QT and other business initiatives including, but notlimited to, leading Edgewater site external audits, managing the POC internalaudit program, leading the POC TRSM program, and driving change within the POCQMS. The individual in this role is expected to act as a change agent, applyadvanced problem-solving techniques and interpersonal skills and be able toinfluence and drive results.


  • Lead external audits for Edgewater facility, including execution of audit readiness activities and coordination of audit logistics with SMEs
  • Provide strategic oversight of all QMS processes and initiate changes, as applicable
  • Lead the POC wide internal audit program
  • Lead the POC wide TRSM program
  • Support the development, monitoring and reporting of key performance indicators (KPIs), which will include assisting in the development of Quality Goals & Objectives across POC

·       Experience with managing complex issues with potentialfor significant business impact

·       Exceptional attention to detail with strongorganizational and technical skills

·       Advanced knowledge of FDA regulations, EU IVDDirective 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 orBusiness Systems for operational excellence

·       Strong analytical skills and data driven mindset

·       Must manage multiple projects simultaneously

·       Must have strong written and verbal communicationskills, including presentations to senior management

·       Key leader during site audits including directinterface with investigators

Required Knowledge/Skills, Education, and Experience

BS/BA inrelated discipline, or advanced degree (preferred), or equivalent combinationof education and experience

Minimumof 10 years of successful management experience in Quality field. Experiencewith FDA Quality System Regulations and audits.

Travelmay be up to 10% for this position 

Preferred Knowledge/Skills, Education, andExperience

Additional expertise inQuality Systems and/or Quality Assurance is a plus as this role is ahigh-ranking position within the QT team at POC.

At Siemens Healthineers, we value those who dedicate their energyand passion to a greater cause. Our people make us unique as an employer in themed-tech industry. What unites and motivates our global team is the inspirationof our common purpose: To innovate for healthcare, building on our remarkablelegacy of pioneering ideas that translate into even better healthcare productsand services. We recognize that taking ownership of our work allows both us andthe company to grow. We offer you a flexible and dynamic environment and thespace to move beyond your comfort zone to grow both personally andprofessionally.

“Successful candidatemust be able to work with controlled technology in accordance with US exportcontrol law.” “It is Siemens Healthineers’ policy to comply fully andcompletely with all United States export control laws and regulations,including those implemented by the Department of Commerce through the ExportAdministration Regulations (EAR), by the Department of State through theInternational Traffic in Arms Regulations (ITAR), and by the TreasuryDepartment through the Office of Foreign Assets Control (OFAC) sanctionsregulations.”

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

If you want to join us in transforming theway healthcare is delivered, visit our career site at

If you wish to find out more about thespecific before applying, please visit:

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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Applicants and employees are protected under Federal law from discrimination. To learn more, Click here.

Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.

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