Location(s): United States ; Massachusetts; Marlborough
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. GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Role Summary: Responsible for contributing to the efforts of the GEHC QA team by establishing and driving standard processes for document development, management, and control. In addition, this role will have the opportunity for cross-functional team facilitation, project management, and documentation-related problem resolution.
Essential Responsibilities: 1. Providing expertise to Global, Business, and Site Quality Assurance personnel with regard to the development and control of quality system documentation 2. Driving continuous process improvements and standardization through data analysis, LEAN efforts, etc. 3. Leading the development and maintenance of document standards, naming/numbering conventions, and templates for QMS procedures, work instructions, and other relevant document types 4. Driving development and implementation of employee training around document management and control with training personnel as required 5. Ensuring the development, management and control of forms and reference documents that are directly related to the document management/document control elements of the GE Healthcare Quality Management System 6. Managing document workflow and ensuring compliance with relevant GEHC Document Management procedures and work instructions 7. Establishing and managing the process for maintaining document cross references 8. Driving the identification and removal of old/obsolete procedures and work instructions from across GEHC and establishing oversight to avoid the duplication of QMS documentation 9. Developing presentations and compiling reports in preparation for Change Control Board and Quality Assurance reviews 10. Participating in/leading the evaluation of alternative document management systems with IT personnel/functional program managers as required 11. Assisting in the authorship of global quality management system related procedures and work instructions as required 12. Leading quality assurance doc control efforts by actively leading or participating as a member of cross-functional improvement teams as required
Quality Specific Goals: 1. Aware of and comply with the GEHC Quality Policy, the GEHC Quality Manual, Quality Management System Procedures and Work Instructions, Quality Goals, and applicable laws and regulations as they apply to this job type/position 2. Complete all planned Quality & Compliance training within the defined deadlines 3. Identify and report any quality or compliance concerns and take immediate corrective action as required 4. Maintain accuracy of QMS documentation; zero defects in document lifecycle management
Qualifications/Requirements: 1. Bachelor’s degree (or high school diploma/GED plus 4 years experience in document control in a QA/RA or medical device/pharmaceutical environment) 2. Minimum 1 year experience working in medical device, clinical, or pharmaceutical environment or similarly regulated industry 3. At least 2 years experience in document management/document control 4. Strong working knowledge of English language (oral and written)
Desired Characteristics: 1. Strong knowledge of medical device and/or pharmaceutical regulations (FDA, ISO) 2. Coursework in Quality Assurance/Control and/or Regulatory Assurance 3. Strong process improvement mindset, passion for quality 4. Ability to interface with top organizational leadership and internal and external customers, responding in a professional manner 5. Technical aptitude (i.e. able to read and comprehend technical documentation, ability to comprehend and execute procedures, demonstrated understanding of system documentation) 6. Demonstrated effective interpersonal and effective teamwork skills 7. Excellent oral and written communication skills 8. Analytical & problem-solving skills/root-cause analysis 9. Strong organizational skills with high attention to detail 10. Prior experience using word processing, spreadsheet, and presentation software 11. Ownership for assigned projects 12. Ability to effectively multi-task (i.e. effectively handle competing priorities) 13. Dependability: Being reliable, responsible, dedicated, committed and fulfilling obligations 14. Adaptable/Flexible: Being open to change (positive or negative) in response to new information, different or unexpected circumstances, and/or to work in ambiguous situations 15. Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others 16. Accepting constructive criticism and dealing calmly and effectively with high-stress situations. This includes continuing to persevere and remain calm in challenging or frustrating circumstances
Locations: United States ; Massachusetts; Marlborough
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