| Senior Quality Engineer (SR QE) Sonoma County Onsite at Sonoma, California, USA |
| Email: [email protected] |
| From: Hemant Rawat, convextech [email protected] Reply to: [email protected] Hi, Hope you are doing good.!! Please let me know if you are interested in the below position Title: Senior Quality Engineer (SR QE) Location: Sonoma County Onsite Duration: 6+ Months MOI: Phone/Skype VISA: NO H1B/CPT --------------------------JOB DESCRIPTION ----------------------- Project Overview: . As a Senior Quality Engineer, you will play a critical role in advancing our Class III cardiac device from IDE submission through PMA approval and ultimately to market launch. Your expertise will be essential in ensuring the highest quality and compliance standards are met throughout the product lifecycle. Key Responsibilities: Design Control and Clinical Trials: Ensure adherence to specific design control requirements. Support the transition of the product into clinical trials, ensuring compliance with regulatory standards. Root Cause Analysis and Investigations: Conduct thorough root cause analysis for issues such as CAPAs, non-conformances, and complaints. Develop and implement effective corrective and preventive actions. Validation and Risk Management: Lead validation activities, including IQ, OQ, PQ. Perform comprehensive risk management and risk analysis to ensure product safety and efficacy. Supplier Management: Develop and maintain strong relationships with suppliers. Oversee supplier quality to ensure compliance with regulatory and company standards. Collaboration and Leadership: Collaborate effectively with cross-functional teams, including R&D, Regulatory, and Manufacturing. Demonstrate strong leadership and communication skills to drive project success. Qualifications: Bachelor's degree in Engineering, Life Sciences, or a related field. Minimum of 5 years of experience in the medical device industry, with a focus on Class III devices is a plus In-depth knowledge of design control processes and requirements for clinical trials. Proven experience in root cause analysis, CAPA investigations, and handling non-conformances and complaints. Strong understanding of validation processes (IQ, OQ, PQ) and risk management methodologies. Experience in supplier management and maintaining supplier relationships. Exceptional collaboration, leadership, and communication skills. Personality Traits: Collaborative team player. Strong leadership qualities. Excellent communication skills. Detail-oriented and methodical. Problem solver with a proactive approach. Application Process Please include "Senior Quality Engineer - Santa Rosa, CA" in the subject line. Thanks and Regards Hemant Rawat US IT Recruiter |Convex Tech Inc. Email: [email protected] www.linkedin.com/in/hemantrawatt Keywords: rlang information technology California Senior Quality Engineer (SR QE) Sonoma County Onsite [email protected] |
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| Thu Jul 11 02:01:00 UTC 2024 |