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.
Role Summary: Supports Design Control efforts and serves as a Design Control resource within the assigned product lines / P&Ls, ensuring compliance with GEHC’s Quality Management System (QMS) and external regulatory requirements.
Essential Responsibilities: 1. Provide guidance to product development teams as to the required deliverables to ensure compliance throughout product development cycle. 2. Review, assess and approve product design milestones and deliverables throughout product development cycle to ensure compliance. 3. Assist engineering/operational quality/compliance representatives to identify compliance risks during the product development cycle. 4. Proactively assess risk, plan and execute audit deliverables. 5. Communicate audit results and recommendations to senior management. Create and drive business wide improvement efforts to improve systemic challenges. 6. Interface with Senior Management and partners during inspections, audits, investigations and report-outs as necessary. 7. Educate and train engineering/operational quality/compliance representatives to ensure adoption of design control best practices.
Qualifications/Requirements: Quality Specific Goals: 1. 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 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. Develop and Demonstrate Subject Matter Expertise on Design Control Global Procedure and associated Work Instructions 5. Monitor & Analyze Design Control metrics within GEHC P&Ls & Sites that correlate Design Control elements to realized Business and Customer Benefits 6. Support Design Control Review Board & Operating Mechanisms.
Qualifications: 1. Bachelor’s degree in engineering (or high school diploma/GED plus 2 years working experience and understanding of product development, manufacturing, quality control and servicing in a medical device environment) 2. Minimum 3 years experience in Quality or Engineering 3. Expertise: Subject Matter Expert (SME) in product design and design controls. 4. Demonstrated experience in a regulated business. 5. Prior experience using word processing, spreadsheet & presentation software 6. Working knowledge of English language (oral and written) a. Provide Independent Assessment of Strategic Program Compliance and ensure desired Quality levels achieved prior to product release b. Support Implementation of GEHC-wide Design CAPAs that improve the effectiveness of Design Control activities
Quality Specific Goals: 1. 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.
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
Desired Characteristics: 1. Previous auditing experience (i.e. GAC, CAS, FDA, ISO, etc.) 2. Knowledge of Quality Systems policies and regulations (ISO, GxP, FDA, and other key 3. regulatory bodies) & strong background in medical device Quality Assurance & processes 4. Understanding of the new product introduction (NPI) process 5. Able to effectively analyze complex quality system requirements & handle multiple tasks with competing priorities 6. Ability to seek & drive alternative solutions/approaches when required 7. Strong business acumen-understands key financial metrics, understands business trends & cycles & is able to influence key business strategies & initiatives, demonstrates knowledge of key business measurements (i.e., market, products/services, suppliers, competition, performance measures) & is able to link Quality Assurance strategy to this framework. 8. Strong technical aptitude (i.e. able to read & comprehend technical documentation, ability to comprehend & execute procedures, demonstrated understanding of system documentation) 9. Analytical/problem solving/root-cause analysis skills
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