About Us: GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.
This role is responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business. The Documentation Coordinator is responsible for the control of Quality Management System (QMS) and quality specific GMP (Good Manufacturing Practices) critical documentation.
Responsible for ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility. Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency at the site.
Develops process improvement plans using a variety of Quality and Continuous Process Improvement tools, including but not limited to Six Sigma, LEAN Manufacturing, 5S, SPC, engineering studies, DOE, Gauge R&R, etc.
Ensures process efficiency and compliance effectiveness through the development and implementation of process verification and validation plans, including Master Validation Plans (Site Level), Validation Master Plans (Product or Process specific plans), and the development of simple yet detailed process flow diagrams that describe critical process interdependencies with respect to process inputs, outputs, risks and impacts.
Supports continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program).
Develops risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc. Supports design mitigation efforts. Develops process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process.
Ensures process compliance through the development of simple yet comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.
Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.
Ensuring that document reviews and approvals are managed in an efficient and effective manner.
Ensuring that all records of document status, outstanding change controls, document reviews, and document approvals are meticulously maintained.
Ensuring that documents comply with established templates, formats, and identification/naming/numbering standards.
Ensuring that document cross-references are accurate and traceable.
Maintaining the electronic document library and developing and/or maintaining a QMS document inventory that includes relevant information regarding document identification, status, effective dating and other pertinent document control information, as required.
Managing and controlling specific quality records, as required.
Distributing and removing controlled documentation to/from points of use, as required
Bachelor’s degree plus 3 years working experience in Quality Engineering or Quality Assurance Management.
Knowledge and experience with Quality Systems policies and regulations 3. Experience using word processing, spreadsheet, and presentation software
Understanding of continuous quality / process improvement tools: (As defined by the local site, e.g. DMIAC, SPC, Lean SS, 5S,)
Ability to communicate using English
Quality Specific Goals:
Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
Complete all planned Quality & Compliance training within the defined deadlines
Identify and report any quality or compliance concerns and take immediate corrective action as required
Meet NPI program milestone dates while approving compliance status of each
Ensure 100% completion/closure of all SPRs/risks before product release to market
Ensure 100% on time CAPA closure for engineering investigations
Change agent with energy, passion & skill to drive change
Understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
Understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing /production process control methodologies, and servicing in a medical device environment.
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