Quality Assurance Engineer I
Quality Assurance Engineer Contractor Description: In this role, The Quality Assurance Engineer contractor will be contributing to the efforts of the Site Quality Assurance team by working with the different stakeholders to facilitate the implementation of procedures, improvement efforts and deploying training activities to fulfill specific requirements. Key responsibilities include: 1. The Quality Assurance Engineer contractor is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. 2. Assists the Quality Assurance Site Manager to ensure/follow up/implement corrective actions that are raised by deviations, internal audit or regulatory inspection 3. Facilitates the implementation of Production and Process Control changes at the site. 4. Participates in efforts to ensure audit-readiness and helping in the resolution of documentation issues, as required. 5. Supports Quality Management Systems documentation workflow and ensures compliance with relevant GEHC Document Management procedures and work instructions, as required 6. Ensures training programs are current and employees are trained in accordance with latest regulatory requirements at a function or segment of the business. Qualifications : 1. Bachelor’s degree (or high school diploma/GED plus 4 years experience work experience) 2. Three years experience working in a regulated medical device, and knowledge of quality system regulations and policies 3. Required experience with some or all of the following: Production and process controls, Design controls, design verification and validation activities, CAPA and risk management 4. Experience performing internal audits P referred Qualifications: 1. Effective oral and written communication skills 2. Analytical & problem-solving skills/root-cause analysis 3. Effective interpersonal and networking skills Thanks and Regards, Rajinder Kaur Infobahn Softworld Inc Ph:408-600-1458 Raji@infobahnsw.com http://www.infobahnsw.com
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