Job Description :
Hi,
This is MURALI from KRG Technologies; We are looking for a QUALTIY ENGINEER or the below mentioned job description. Kindly forward me your resume, rate and contact details for further process.
Job Title: QUALITY ENGINEER
LOCATION: CARLSBAD,CA
Duration:Contract
Strong familiarity with regulatory requirements (e.g. ISO 13485, CFR 820 & EN ISO 14971)
Familiarity with EN ISO 60601-1, EN ISO 60601-1-8, EN ISO 80601-2-12 a distinct advantage.
Experience in risk evaluation techniques, e.g. HHE/HHA, Product Risk Assessment, SFMEA/HHA, DFMEA, PFMEA & fault tree analysis.
Familiarity with Hardware EE Design & Development: Design Margin, Component Derating, Creep & Clearance, In Circuit Test, IPC, IEC 61000, Design of Experiments & Reliability Analysis.
Familiarity with Hardware ME Design & Development: Stack Up and Tolerance Analysis, Key Inspections Analysis Material Analysis, Design of Experiments & Reliability Analysis.
ASQ CQE, CRE, CSQE certification desirable, but not essential.
Review new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulations Design phases.
Participate on cross-functional teams to review marketing requirements and to develop concise, unambiguous, con-conflicting and feasible product requirements that support the market needs.
Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, and risk management report
Assist in the creation of verification and validation test plans. Oversee testing and analysis for standards and product requirements compliance.
Provide guidance and direction for sample size and statistical analysis of verification and validation test results. Experience Statistics stools experience an advantage e.g. Minitab.
Provide training to project teams on procedures, verification, validation, statistical methods and design controls.
Create a risk management plan, perform product risk assessment, facilitate the failure mode effects analysis, and create a final risk management report.
Review Design History Files and Technical Files for conformance to applicable requirements.
Assist, when appropriate with internal and supplier audits.
Provide Quality support to facilitate the rapid resolution of product complaints and/or safety issues.
Support the Regulatory Department in writing technical submissions.
Familiar with DMAIC or DMADV(DFSS) methodologies
Stability, Biocompatibility, Sterilization, Ship Testing, HALT/HASS.
Secondary Skills:
Knowledge, understanding and implementation experience with medical device quality systems, manufacturing operations, supplier quality, and regulatory requirements
Experience in program or project leadership and the associated communication, presentation, team facilitation, and influence management skills
Ability to communicate effectively in multi-discipline, cross cultural environment and levels of organization
Prior experience in a medical device
Computer literate and experience with PCs, networks, and applications. Some travel required
MURALI | Resourcing Executive
KRG Technologies, Inc.,
25000 Avenue Stanford, Suite #243, Valencia, CA 91355
Direct Ext : 257 |
An Inc.5000 Company
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