Position Title: Quality Engineer - Technical Transfer
Position Number: 354713
Location: Irvine, CA 92618
Position Type: Temporary
Required Skill Set:
Audit, Documentation, Engineer, FDA, MS Excel, Quality Management
**Only U.S. Citizens and those authorized to work in the U.S. can be considered as W2 candidates.**
Job Title: Quality Engineer - Technical Transfer
Location: Irvine, CA
Duration: 10+ Months
• The Quality Engineer partners with multiple stakeholders across the organization, internally and externally to ensure the production of quality products.
• Responsibilities include collaborating with internal and external stakeholders when issues occur, including root cause analysis and process improvement conducted both internally and at the supplier; provide performance feedback through communication and auditing.
• Collaborates with cross functional team of Manufacturing Engineers, Quality Engineers, Buyer/Planners, Production and Procurement Develops, modifies, applies and maintains quality evaluation and control systems and protocols for processing materials into partially finished or finished materials product.
• Provides technical guidance and quality compliance for Supplier Quality engagement on products, subassemblies and parts and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and Client requirements.
• Collaborates with engineering laboratory and production functions to ensure quality standards are in place.
• Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Designs and analyzes inspection and testing processes, mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess control and manage risks of product quality and determine the responsibility for products or materials that do not meet required standards and specifications.
• Audits quality systems for development acceptance criteria (parameters based on product result).
• May undertake root cause analysis of incidents requiring corrective action.
• Ensures that corrective measures and deviation meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
• May be certified in lean and six-sigma quality methodologies and utilize quality tools to help drive continuous improvement.
• Bachelor''s Degree.
• The ability to fluently read, write, understand and communicate in English.
• No prior experience required; however prior experience in an FDA regulated environment preferred.
• Experience with Quality Management System.
• Familiarity with regulatory reporting requirements for medical devices (e.g. MDRs, Vigilance reports, etc.).
• Familiarity with medical device complaint files and quality records; knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard.
• Strong computer skills (including Excel).
• Bachelor''s Degree.
• Corrective action.