Quality Engineer Medical Device - San Diego- CA

Stellar Consulting Solutions is a boutique business & technology consulting company headquartered in Atlanta, GA. We deliver high quality, agile, and experienced workforce for niche technology projects of any scale. We help forward thinking clients to solve specific problems by understanding their needs and align talent that can move fluidly to match skill supply and demand on a real-time basis. Stellar Consulting has a unique combination of technical and digital skills to recruit, engage, and retain qualified talent. We have a stellar reputation for striving to achieve high ethical standards. Our use of Innovative techniques and industry best practices has made us one of the fastest growing boutique firms delivering to enterprise business. Title: Quality Engineer Medical Device Location: San Diego- CA Hybrid 3 days onsite 2 days WFH Job Description: Responsibilities: Support modification and maintenance of quality system procedures for the design center that comply with ISO 13485:2016 and 21 CFR 820 requirements Implement Corporate and Business level Quality System procedures for the design center locations under supervision Facilitate internal quality system audits per the procedural requirements Support the management of external audits Lead or Support the development of content for the management review process Update and report on monthly quality metrics Provide inputs on revisions to Corporate and Business level procedures as necessary Support supplier management efforts for the design center Maintain outsourcing relationships with internal customers and suppliers by management of quality agreements Scope of Responsibilities: Work is performed without appreciable direction Determine and pursue course of action necessary to obtain desired results Educational Requirements: A minimum of Bachelor's degree in Science or related discipline Certified ISO 9001/13485 Lead auditor is desirable Knowledge of Design Control, Risk Management and QMS processes Minimum 1-2 years of experience developing and sustaining quality systems of medical devices Knowledge and Skills: Exposed to internal and external audits as an auditor and/ or auditee Some knowledge of applicable regulatory and industry standards (21 CFR 820, ISO 13485, MDD, MDR, ISO 14971, etc.) Good technical writing, communication skills, and managing small quality system project Desirable knowledge with Design Control/ Change control process, CAPA, Deviations and Non-conformances Design Control EU MOD/MOR Change control Risk Management Process Validation Identification of CTQ's Handling of deviations and non-conformances Test method validations CAPA- Root cause investigation and implementation of corrective / preventive actions Proper Use of Statistics (Sampling Plans) Advise on Regulations and standards Liaise with Manufacturing Plants Provide functional support to cross-functional teams G Support Internal and external audits Requirements: Bachelor's Degree A minimum of 9 years of relevant experience or a combination of equivalent education and relevant experience Minimum 2 - 3 years of experience supporting design assurance for medical devices Extensive knowledge of applicable regulatory, Corporate and/or Unit requirements. Applicable Regulatory and Industry standards (21-CFR-820, ISO '13485, MOD, MOR, ISO 14971,ISO 10993, etc.) Knowledge and Skills: ? Quality Engineering tools, Statistics, Problem Solving, strong Interpersonal Skills, Leadership, all forms of Communication ASQ Certificate(s) desirable (but not required) Kind Regards, Vasu Bartarya Sr. Recruiter at Stellar Consulting Solutions, LLC. Mobile/WhatsApp: Web: Email: