Quality Engineer

Company: US Tech Solutions
Location: San Diego
Posted on: May 26, 2023

Job Description:

Duration: 9-10+ months(with possible extension) --- 3 Must haves on the resume: Risk Management Knowledge, Design controls exposure, Knowledge with Engineering change control processes, targeted knowledge with MDR 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 ---Wetermine 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) About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit .

Keywords: US Tech Solutions, San Diego , Quality Engineer, Engineering , San Diego, California