Represent and provide support for the Commercial Product Quality department when working on post market regulatory Hematology, Hemostasis and Plasma Proteins reagent and instrument related issues from the Escalation Review Councils (ERC), as well as support and drive to closure Product Quality Committee (PQC) and Field Corrective Action decisions and reporting, as required, related to reagent and hardware/software (HW/SW) Laboratory Diagnostics products. Evaluate safety complaint escalations and make decisions on Medical Device Reporting (MDRs), fully documenting those decisions. Provide support in all areas associated with MDR/MDVR reporting and trending. Provide Commercial Product Quality support for reagent and HW/SW Laboratory Diagnostics Product Health Teams. Provide Commercial Product Quality support for both internal and external audits (3rd Party Auditors, FDA, etc.). Review and approval of all customer facing documentation. Corrective and Preventive Action (CAPA) experience needed. Expected to perform at an advanced level in the field of Commercial Product Quality and apply advanced skills to resolve complex problems. Provide leadership to the Product Quality Committee in assessing and addressing product defects.
Display of a high level of critical thinking in bringing successful resolution to high-impact, complex, and/or cross-functional problems is expected. Demonstrate a significant knowledge of organization's business practices and issues faced and contributions to problem resolution of those issues. Experience in Quality Systems, Medical Device Reporting, Field Action and CAPA recommended.
Good writing, communication and organizational skills necessary.
Job Family Responsibilities: Performs root cause analysis and implementation of corrective action for process related concerns. Assist Quality manager in establishing, implementing and maintaining the quality management system. Develop training to build quality awareness. Conducts economic implication analyses, prepares reports of findings and carries out complicated implementation and training assignments. Develops and provides guidance to multiple operations for QMST. Conduct audits, including closing out audit findings, creating audits finding reports and determine proper corrective and preventive actions.
Education: BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas.
Knowledge and Experience: Demonstrates and applies comprehensive knowledge of field of specialization to the successful completion of complex assignments. Demonstrates advanced knowledge of concepts, practices, and procedures of particular area of specialization. Demonstrates significant knowledge of organization's business practices and issues faced and contributes to problem resolution of those issues. Typically 8-10 years of successful experience in related field and successful demonstration of Key Responsibilities and Knowledge as presented above. Advanced degree MAY be substituted for experience, where applicable.
Direction of Others: Provides specialized guidance or train support and/or professional staff. Leadership qualities and role model qualities demonstrated.
Key Working Relationships: Primarily intra organizational contacts and external contacts.
Job ID: 185181
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
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