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Sr. Quality Engineer- Ultrasound

Job Description

The Sr. Quality Engineer is responsible for driving quality to ensure products or services being designed, produced and supported to meet or exceed business, customer and regulatory requirements and expectations. Participates in the definition of requirements, design, defects and change management process to assure the products or services continue to meet business, customer and regulatory requirements. Uses various data sources and inspections to identify opportunities to improve product quality. Participates in cross-functional teams with other business and engineering disciplines. Provides independent oversight and review of project deliverables throughout product lifecycle. Provides leadership responsibility and accountability to the organization for own decisions and actions, while also holding others accountable for the same.
 
Specifically, the Sr. Quality Engineer is responsible for:
  • Driving quality and compliance across teams, process and products considering: usability, reliability, performance, supportability, manufacturability, safety, security, privacy, serviceability, sustainability and costs
  • Participating in design and milestone reviews, reliability and risk management activities during product lifecycle
  • Performing independent technical assessment and acceptance of on engineering or production deliverables
  • Acting as a single point of contact (person assigned to project team) responsible to ensure that system design meets quality and compliance standards for each milestone
  • Functioning as a subject matter expert on V&V techniques and management of electronic records and signatures.
  • Leading quality related problem solving and root cause analysis during design, manufacturing and install base support
  • Engaging with engineering teams to manage and resolve non-conformance design issues helping drive related costs down.
  • Using applicable data sources and statistics to report on product quality performance and taking action in accordance with data.
  • Ensuring that design meets quality and compliance standards
You are a part of Ultrasound Business. This is a key business along the continuum of care and has a broad product portfolio of advanced diagnostic solutions. Our mission is to design, produce, and deliver every solution as if the life of someone we love depends on it. Every day, we empower and enable our customers to save lives using our innovative, market leading technology. We are searching for passionate leaders to join us as we strengthen our product portfolio, expand our services and solutions, and bring game changing technology to market.

To succeed in this role, you should have the following skills and experience:
  • Bachelor's Degree: Engineering or 4 year technical degree
  • 4+ years’ experience working in a regulated industry. Medical device experience is a plus 21CFR 820/11, ISO 13485, ISO 14971, IEC 62304.
  • Have an understanding of quality philosophies, principles, systems, methods, tools, standards, organizational and team dynamics, customer expectations and satisfaction, leadership, training, interpersonal relationships, improvement systems, and professional ethics.
  • Have understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements.
  • Be able to develop and implement quality programs, including tracking, analyzing, reporting, and problem solving.
  • Be able to plan, control, and assure product and process quality in accordance with quality principles, which include planning processes, material control, acceptance sampling, and measurement systems
  • Reliability Engineering expertise – practices and tools
  • Product and program, engineering practices and KPIs improvement efforts with Product Quality in mind
  • Good communicator, presentation, influence and conflict resolution skills
  • ASQ Certified Quality Engineer is a plus 
  • Audit experience is a plus
  • System V&V experience is a plus

*LI-WC1

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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