Quality Engr 2 job in San Diego, CA
Vacancy has expired
San Diego, CA CorTech LLC
| Job Ref: | 343246 |
| Employer: |
CorTech LLC |
| Job Type: | Contract |
| Salary and Benefits: | 59.84/Per Hour |
| Remote: | No |
Location |
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| City: | San Diego, CA |
| Post Code: | 92121 |
| Map: |
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Description |
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For certain roles at at this client, assignment is contingent upon the Employer of Record?s receipt of sufficient proof that you are fully vaccinated against COVID-19 (meaning two weeks have passed after the last injection of Pfizer/Moderna or two weeks after receipt of the J&J). In some locations, testing for COVID-19 may be available and/or required. Requests for accommodation will be considered pursuant to applicable law. CorTech is seeking to hire a Quality Engr 2 for our client in San Diego, CA! Benefits Available! Weekly Pay! $59.84/Hour Shift: 1st Shift ? 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 ?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) BD04123JD | |
ref: (343246)
1110 days ago
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