Quality Coordinator – Life Sciences Complaint Handling Unit
Posted 8/5/2017 9:58:15 AM
Business Segment: Healthcare Quality
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: Quality Systems Coordinator provides support for the development, maintenance, and monitoring Quality Management System to ensure its continued effectiveness.
Essential Responsibilities: Primary Responsibilities 1. Timely complaint registration, escalation, and management 2. Coordinate complaint handling activities including investigation, corrective action, document review and approval, and complaint record closure. 3. Coordination of global quality activities including data collection, evaluation, trending, and reporting.
Additional Responsibilities 4. Participate in and facilitate quality review boards as assigned 5. Coordinate status reporting, and driving achievement of quality goals and department initiatives 6. Identify, report, investigate, and escalate quality or compliance concerns with strong attention to detail 7. Manage controlled documentation and records within the Life Sciences Quality Management organization, as required 8. Participate in the implementation and maintenance of global Quality Systems computerized systems and tools 9. Promote a collaborative environment among the Quality Systems team, internal and external customers, and business partners 10. Participate and support audits and inspections across the Life Sciences business 11. Provide support and backup for team members within the Quality Systems organization 12. Support key activities and initiatives as assigned.
Quality Specific Goals 1. Maintain awareness 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 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 Quality System Regulation (QSR) and Current Good Manufacturing Practices (CGMP) requirements 5. Timely complaint handling and reporting 6. Timely review of documentation and records 7. Accurate quality data reporting and signal response 8. Provide objective evidence of global processes through compliant documentation
Qualifications/Requirements: 1. High school diploma/GED and minimum 2 years working experience in a regulated environment environment. 2. Ability to work independently in a fast-paced environment with little supervision 3. Ability to communicate effectively in English (both written and oral) 4. Strong typing and data entry skills with great attention to detail. 5. Prior experience using spreadsheet and presentation software.
Desired Characteristics: 1. Bachelor’s degree in a scientific discipline 2. Demonstrated knowledge of 21CFR part 210, 211, and/or 820 3. Demonstrated knowledge of ISO 9001 and 13485 4. Demonstrated knowledge of International Council for Harmonisation (ICH) Quality Guidelines 5. Demonstrated knowledge of Quality Management System improvement 6. Previous experience conducting Investigation, CAPA, and/or Post Market Surveillance 7. Previous experience working in medical product Quality or Regulatory role(s). 8. Working knowledge of GEHC products
Locations: United States; Massachusetts; Marlborough
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