Siemens Quality Assurance Document Control Coordinator in Berkeley, California
Quality Assurance Document Control Coordinator
Job Family: Internal Services
Division: Siemens Healthineers
Business Unit: Strategy & Innovation
Requisition Number: 201391
Assignment Category: Part-time regular
Experience Level: Entry 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 Quality Assurance Document (QAD) Control coordinator is responsible for managing the Document Management System that complies with quality system requirements, for final release of manufactured product, and for supporting the training program for Siemens Molecular Diagnostics.
• The electronic controlled document management systems, including management of Quality Records, Design History Files, Engineering Change Orders, Design History Record reviews, and Batch/Raw Material Release.
•Final product lot release activities and scans of executed batch records and raw material QA review acceptance. Correspond with appropriate stakeholders.
•QA review of label documentation, verifies printed sample labels for correctness.
• Overseeing the archiving process and inventory listings for on-site and offsite records, retention and destruction of archived documents, for properly maintaining documents and becomes actively involved, as needed, to meet schedules and resolve problems associated with the document archive process and frequently interacts with functional peer groups at various levels.
• Create, monitor, and administer the management of Purchase Orders for Document Control activities, including off site storage.
• Assists with processing changes through the Change Control, ECO, and Document change notices.
• Reviews documents submitted to ensure the use of correct templates, types, training, and quality requirements prior to posting for release.
• Review document changes and provide effective communications of changes for site awareness and to facilitate training requirements.
• Administer and maintain compliant periodic review scheduling and reporting.
• Administer and maintain records and number issuance for equipment and log notebooks.
• Manages the numbering system, version numbers and effective date of all documents
• Organizes, administers and oversees the maintenance of an electronic and hard-copy organizational structure for effective storage and retrieval of all documents
• Serves as in-house expert on creation and closure of change controls
• Strategize within Quality and cross-departmentally to assess effectiveness of current document control and training systems and processes and make recommendations and plans for improvements
• Develop metrics and reports to assess the performance of Controlled Document
• Quality Document Control Subject Matter Expert (SME) before, during, and after inspections and audits
• Serve as the quality operational technical representative on any teams evaluating new documentation processes or systems.
• Administer system updates to the document control system as required and support training through system administration.
• As the SME participate and collaborate with Business Units/departments to ensure QMS compliance and alignment of local SOP’s as required with common Business Unit SOP’s.
• Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.
• Science or related degree preferred
• 3+ years’ experience in Quality roles
• Electronic document management system control/administration and/or management experience, ideally in the role of system owner; with 1-2 years LMS implementation and control/administration or system owner
• Medical Device industry
• Experience with Lotus Notes Document Change and SAP document structures
• Working knowledge of US / EU regulations and guidelines, including 21 CFR Parts 803, 820
• Strong technical writing skills
• Advanced software skills (including SharePoint, Visio, Project, Acrobat Pro, Microsoft office, and SAP), and demonstrated troubleshooting and problem-solving techniques
• Ability to develop and present training materials to large groups, author and update controlled document procedures as needed
• Proven ability to work under tight deadlines and pressure in a composed manner
• Comfortable communicating with all levels of staff, including executives
• Effective organization, communication, and team orientation skills
• Project management skills prefers
• On site management of the document control functions with the ability to travel as business would require.
Job Family Responsibilities:
Completes maintenance, organization, and distribution of technical records and information Conducts complex analysis, project/process reporting and database/data management Develops programs, statistical reports, budgets and presentations
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 a broad knowledge of field of specialization through successful completion of moderately complex assignments. Successfully applies complex knowledge of fundamental concepts, practices, and procedures of particular area of specialization. Demonstrates knowledge of organization's business practices and issues.Typically 5-8 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.
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/PayTransparencyNotice_JRFQA508c.pdf .