Senior Quality Systems Engineer (Medical Device/IVD)
Business Unit: Diagnostics
Requisition Number: 223369
Primary Location: United States-California-Berkeley
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 10%
At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably. A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics.
Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape.
The QA Engineer 4 is responsible for multiple cross functional quality management system elements within the Siemens quality management team. Provide support across Molecular departments and sites to facilitate an environment of compliance and meeting business objectives. Strive to ensure that appropriate quality management system practices are in place and followed throughout the organization. The successful candidate will report in to the Quality System Manager within the business function
The position requires extensive knowledge on the disciplines within a medical device/IVD QMS. This role requires the capability to effectively assist compliance through accurate and reliable documentation. Must be able to work independently, interface effectively, and demonstrate a high level of reliability, integrity, and personal accountability, as a member of the Siemens quality management team. Primary responsibility for leading internal audits and manages the Audit and CAPA program meeting MD/IVD regulations.
• Interface within the CAPA database tool and cross functional department representation to manage CAPA workflow, coordinate CAPA meetings, acquire and report on CAPA KPI’s, and ensure on time processing and compliance to prevent reoccurrence of non-conformities. SME for the CAPA program and interface with CAPA owners to ensure on time and compliant CAPA records.
• Be a leader in introducing, coaching, and coordinating business improvements through training, new quality tool development, implementation, and authoring or editing SOP’s.
• Lead improvement projects within the QMS through supportive tools, databases and project plans.
Requires BA/BS in related field
• 6-10 years’ experience with all elements of the medical device or IVDD quality management system including extensive experience in the following areas:
• Leading internal audits within a medical device/IVDD environment.
• Certified Lead Internal Auditor; with at least 3 years of leading internal audits and developing site schedules; 5 years of experience taking part in audits within a medical device or IVDD company
• Formulation from cross functional teams key process Indicators supporting management review.
• Coordination, leading, and implementation of quality data base tools, SW systems or EQMS technical solutions.
• Advanced proficiency with the Microsoft Office Suite required; metric and KPI reporting.
• Computer Skills (Word, Excel, PowerPoint, Minitab, Visio, Microsoft Project/scheduling, Metric/chart creation).
• Willingness to travel 10% required.
• Effective communication, collaboration, and strong technical writing skills.
• Experience authoring and presenting technical and/or QMS training to cross functional departments.
Preferred Knowledge/Skills, Education, and Experience
• BS degree in Life Science strongly preferred.
• ASQ CQE/CSQE or equivalent
• 1-3 years’ experience with corrective action data base administration.
• Supplier assessment and approval through site audits.
• Six Sigma Certification preferred
• Manage the internal audit program by leading internal audits, timely audit scheduling, and audit training.
• Participate and
collaborate with Business Units/Areas, departments, to facilitate compliance
and align local SOP’s as required with common Business Unit SOP’s.
• Support QA releases of final product release, executed batch records, labeling, and raw materials. Correspond with appropriate stakeholders to ensure regulatory requirements/specifications are met.
• Author, maintain,
and present KPI’s through data exporting and metrics with professional
• Track and report resource management, project deliverables, and key milestones.
• Apply and exercise audit readiness skills and techniques within the organization and participate in external regulatory audits as a member of the Siemens quality management team.
• Coordinate, train, and support audit readiness and act as the external audit ready room manager.
Knowledge/Skills, Education, and Experience
• Experience preparing
for external QMS and regulatory audits, audit room manager/coordinator, train
and prepare staff.
• First-hand knowledge of applicable US (21 CFR 820) and EU (ISO 13485) quality system requirements with experience in IVDR/MDR and MDSAP.
• Highly developed writing, communication, and interpersonal skills with the ability to work on diverse teams located at different geographical locations.
• Corrective and
Preventive Action programs and Root cause analysis
• Expertise knowledge
level and application of QSR’s, MDR/IVDR, IVDD, EU/ISO 13485, 14971, and MDSAP
• CATSWeb or CAPA database applications
• QSR compliant complaint and reporting processes