Siemens Senior Quality Systems Engineer - Medical Device Lead Auditor in Berkeley, California
Senior Quality Systems Engineer - Medical Device Lead Auditor
Job Family: Quality Management
Division: Siemens Healthineers
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%
Siemens is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. As a global technology company, Siemens is rigorously leveraging the advantages that this setup provides. To tap business opportunities in both new and established markets, the Company is organized in nine Divisions: Power and Gas, Wind Power and Renewables, Energy Management, Building Technologies, Mobility, Digital Factory, Process Industries and Drives, Healthineers and Financial Services.
With 45,000 employees Siemens Healthineers is one of the world’s largest suppliers of technology to the healthcare industry and a leader in medical imaging, laboratory diagnostics and healthcare IT. All supported by a comprehensive portfolio of clinical consulting, training, and services available across the globe and tailored to customers’ needs. So that more people can have a life that is longer, richer, and more filled with happiness.
For more information, please visit: http://www.usa.siemens.com/healthcare
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 QMS. This role requires the capability to effectively assist and ensure a compliant quality management system 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 program.
Manage the internal audit program by leading internal audits, timely audit scheduling, and training to ensure regulatory compliance.
QS Site subject matter expert (SME) for Internal/External Audits and applicable regulatory requirements.
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 manage audit readiness and act as the external audit ready room manager.
Participate and collaborate with Business Units/Areas, departments to ensure QMS compliance and align local SOP’s as required with common Business Unit SOP’s.
Be a leader in introducing, coaching, and coordinating business improvements through training, new quality tool development, implementation, and authoring or editing 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 presentations.
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.
Lead improvement projects within the QMS through supportive tools and databases.
Develop and maintain detailed project schedules in Microsoft Project.
Track and report resource management, project deliverables, and key milestones.
Required Knowledge/Skills, Education, and Experience
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.
Experience preparing for external QMS and regulatory audits, audit room manager/coordinator, train and prepare staff.
Certified Lead Auditor; with at least 3 years of leading internal audits and scheduling them; and 5 years of experience taking part in audits within a medical device or IVDD company
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
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.
Expertise knowledge level and application of QSR’s, MDR/IVDR, IVDD, EU/ISO 13485, 14971, and MDSAP.
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
CATSWeb or CAPA database applications
QSR compliant complaint and reporting processes
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, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.
EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more, Click here at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm .
Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here at https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf .