Description de l'offre
This role is responsible for providing manufacturing process support for product acceptance at Production, in accordance with documented procedures/practices.
The Final Acceptance Specialist will implement and reinforce site Quality Managment System (QMS) activities related to Manufacturing at Production to ensure products specification per site process quality.
1. Reviewing of production documentation and assisting with batch release procedures
2. Responsible for medical device inspection at production, ensuring quality and regulatory compliance in accordance with documented procedures.
3. Ensures process efficiency and compliance through production implementation; Device History Record including deviations, concessions and ship matrix per regulatory approvals.
4. Supports product/process quality through feedback obtained by CAPA Program and improvement opportunities.
5. Support on-going site learning (investigation) towards improvements
6. Performs a broad variety of tasks to support product and process as assigned by the departmental manager.
B.S. Degree or technical field certification/ equivalent experience
• 2-3-year experience in a medical device or equivalent industry.
• Thorough familiarity with cGMPs, ISO13485, 820CFR Regulation
• Skills with office tools (Excel / Word/PPT)
1. Statistics education and or training
2. Committed to performance with prioritization capabilities
3. Confidence personality with a strong communication/ interpersonal skills
4. Good technical skills
5. Team player
6. Familiar with Continuous Improvement methodologies, including Six Sigma
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.