- Establish quality engineering strategy and plan for managing end-to-end product quality throughout the life cycle for ultrasound and transducers products.
- Mentor, and coach teams in the creation of design and development plans, integration, verification and validation plans, software requirements specifications, design documents, design reviews, Risk Management File (RMF), test strategy, reports, and traceability matrices.
- Lead continuous improvement of Design Controls, Software Development Life Cycle (SDLC), Process and Tools Validation processes incorporating internal and external industry best practices.
- Ensure compliance to Design Controls and SDLC throughout the development process, ensure robust assessment of on-going issues, product changes, and monitoring of field performance.
- Foster organizational compliance to the Quality System including ongoing training and education on the Quality Management System (QMS) and SDLC framework.
- Participate in internal and external audits as Subject Matter Expert (SME) on Design Controls, SDLC, V&V, Process & Tools Validation, Risk Management and more
- Leads a staff of Quality Professionals with following responsibilities:
- Responsible for oversight on development activities across the business to ensure that the teams have a robust Product Milestone Reviews, Design Controls and SDLC Compliance, Design History Files (DHFs), Risk Management Plan, Integration, V&V strategy during development, manufacturing, and effective post market plans prior to launch.
- Ensure robust investigation and performance evaluation prior to product changes and ensure effective monitoring to assess product performance and identify improvement opportunities.
- Ensure that Design Controls and SDLC systems maintain compliance to external regulatory requirements and internal Quality System procedural requirements.
- Actively engage R&D, Manufacturing and Sustaining engineering regarding process validation and ensure processes are adequately validated including a review of validation methodology, sample size determination, and results of process validation meet requirements.
- Participate in the development and changes, including review and approval of Risks, Reliability, Design and Process FMEAs applicable to the product and manufacturing sites.
- May review and approve supplier control plans, FMEAs, and provide nonconformance feedback to suppliers through the Supplier Corrective Action Request (SCAR).
- Participate in CAPA review (CRB) and Change Control Boards (CCB), review and approve related processes ensuring smooth operation, implementation effectiveness and compliance to regulatory requirements and Siemens Healthineers policies.
- Define and Monitor product quality metrics (KPIs) and conduct cross-functional meetings with KPI dashboard driven decision making and continuous improvements.
- Represent quality engineering in periodic execution control, operational reviews, management reviews, audits, and inspections. As SME provide organizational leadership for Product Lifecycle Processes.
- Bachelor of Science in Engineering, Systems Engineering or related field.
- Minimum 5 years of experience as QE, QA, Product Design & Development or Project Management in FDA QSR and EU MDR regulated medical device company.
- Experience in Class II or III medical device, SaMD, CAPA, Risk Management.
- Effective Influential and Lead by Example Leadership, Clear Communication, Self-driven Cross-Functional abilities in a global environment is a must.
- Experience in Software Development, Software Quality, SDLC, Agile is a plus
- Experience with regulatory audits, milestone reviews and presentations
- Strong Product Design, Development, Troubleshooting experience. Working knowledge of CAPA, risk management, hazards analysis, corrections and recalls, defect management, complaint handling and statistical analysis techniques is a plus.
- Experience applying ISO 13485, 14971/24971, IEC 62304 standards to a complex product. Able to demonstrate working knowledge of QMS and understanding of Regulatory practices. Detailed working knowledge of 21 CFR 820, IEC 60601-1 standards.
- PMP, ASQ, CQE, Audits & Inspections and other certifications are a plus.
Organization: Siemens Healthineers
Company: Siemens Medical Solutions USA, Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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