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Jr Quality Engineer

3 months ago

Hercules, United States TCWGlobal Full time

Jr Quality Engineer Hercules, CA ( Onsite 2-3 days- *Local candidates only)W-2 position $48hr ( Weekly pay + Benefits )6 month contract ( Excellent potential for permeant and extension)Full-time: M-F Hybrid - onsite 2-3 days a week.Our client is a global team of innovators, leaders, creators, builders, and problem solvers. They develop state-of-the-art instruments and reagents for life science research laboratories and healthcare facilities all over the world. Together they are helping people everywhere live longer, healthier livesThe Quality Engineer will help facilitate the consolidation of legacy CDG and LSG product risk management files, including: Facilitating risk management assessments, updating risk plans and reports, consolidation and updating product system hazard analysis files in accordance with established company procedures and applicable standards. Coordinate and facilitate meetings with cross functional stakeholders as needed to obtain information and data needed for completeness and accuracy of risk profiles for existing hazards, and identification of new risks and hazards as needed. Escalate events to Management that require additional inputs or mitigations. The Quality Engineer will support product complaint investigation by: Coordinate investigation activities between cross functional subject matter experts (SME). Review and approve investigational documentation and ensure complaint workflows are complete and required supporting documentation is attached. The Quality Engineer will support generation of monthly and quarterly product quality dashboard, including: Generating monthly metrics reports Analyze significant trends and coordinate mitigation with SMEs. Present findings to complaint review boards and RAQA managementHow You'll Make An Impact:Support a quality environment and mindset throughout the business by working closely with technical SMEs and global RAQA stakeholders to update and maintain product risk management files. Upload risk management files into Veeva.Work closely with technical SMEs to ensure customer complaint investigation activities and files are completed and documented.Work closely with product experts (R&D, Marketing, Product Support and Manufacturing) to generate product quality metrics and analyze trends as required.Ability to work in an ever-shifting environment and possess a high level of patience to support cross functional teams with shifting priorities.A self-starter who can work independently and possesses a sense of ownership and accountability to the activities assigned to them.What You Bring:Bachelor's degree or equivalent in a related technical or engineering discipline**local candidates only** W-2 Contract. 1-2 years experience in Quality Or Education related to Quality EngineerBasic knowledge of and application of principles and theories of quality engineering.Understanding of Medical Device/GMP/ISO regulations (ISO 14971, ISO 13485, MDSAP and FDA CFR Part 820), and FDA CFR Part 210/211 is a plusBasic understanding of risk management regulations, principles, and application.SAP experience a plus.Proficient in Microsoft Office, Livelink, Visio.Please send your resume. Thank you