- 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
- 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
Organization: Siemens Healthineers
Company: Siemens Medical Solutions USA, Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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