Quality Engineer - Medical Device (Fulltime/Permanent-)
Santa Teresa, CA, US
hace 20 horas
source : PostJobFree

Quality Engineer JOB SUMMARY : Quality Engineer (QE) will play a key role in improving, creating and maintaining product quality and process improvement initiatives throughout the company.

QE is responsible to maintain and deploy company quality management system processes.ESSENTIAL FUNCTIONS : Maintain company production processes and work instructions to support Production and Quality teams in building and testing company products.

Provide support to Production and Quality teams and follow approved production processes to meet company business goals, improve product quality, First Pass Yield (FPY) and customer satisfaction.

Collaborate with Engineering, Operations to facilitate new product introduction to Manufacturing.Monitor in-process, final Quality Control, product testing performance.

Apply statistical process control method for analyzing data to evaluate effectiveness of company quality management system.

Facilitate customer audit, company Management Review, Corrective and Preventive Action process, Supplier Corrective Action (SCAR) process and act as a focal point for product issue reports.

Work with cross-functional team and / or suppliers in investigation and root cause analysis.Develop corrective and preventive actions for reported quality issues with effective measurement.

Facilitate Nonconforming material (NCR) and Material Review Board (MRB) activities.Conduct Internal audits, Supplier audits and identify areas that need improvement.

Report significant issues identified during quality assurance activities and reported issues should be associated with recommended corrective action or process improvement.

Qualify and implement alternative manufacturing materials, processes, tools to address quality and production efficiency concerns.

Work with customers, suppliers and management at all levels to address quality related concerns.Act as Technical Liaison between Engineering and Production teams to investigate and resolve production technical issues on the floor.

EDUCATION / EXPERIENCE : BS degree in Electrical Engineering or Computer Engineering required.5+ years experience in Quality Assurance & Control of medical Minimally Invasive Surgery (MIS) device (at PCBA and box build levels).

Experience in assembly / test operations, supplier qualification, incoming & final inspection.Must be computer literate, with minimum 5 years experience performing computerized work functions.

Candidate should have ability to utilize software programs such as MS Word, Excel, Publisher, Great Plains etc.ADDITIONAL SKILLS AND KNOWLEDGE : Working knowledge of medical device regulations (FDA 21 CFR 11, 820), international regulations and standards (ISO 13485 : 2003).

Strong writing and presentation skills.Have ability to interpret Engineering drawings.Ability to develop, update quality management system processes and work instructions.

Must be familiar with non-compliance trending statistic analysis methodology and tools.Must be familiar with defect / issue / complaint handling process and tools.

Work well with minimal supervision and have ability to manage multiple tasks effectively.Ability to stay focused and perform required duties in a very fast paced work environment.

Able to lift items not exceeding 60 lbs.No sponsorship visa (H1-B, etc) candidates at this time, sorry.Qualified candidates must submit their resume in Microsoft Word format along with at least three professional references to : COYOTE TECHNICAL & EXECUTIVE SOURCING Phil Montoya Director of Sourcing 220 Miracle Mile, Suite B219 Coral Gables, FL 33134 P : Fax : Like us on Facebook Link up on LinkedIn Follow us on Twitter For more job openings, please visit

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