|
WHAT
IN
Quality Engineer
Job
Medtronic
US
-
Santa Ana,
California
Job Code - 67821
Position - Full Time - Regular
Job First Active on: Thursday, November 05, 2009
APPLY TO THIS JOB (You will be applying directly to Medtronic for this position!)
JOB DESCRIPTION: Quality Engineer
Ensure products and assemblies manufactured in Santa Ana Operations meet specifications and are developed and manufactured with highest product quality and meet all applicable product quality, design and manufacturing process requirements. Provide leadership in areas of process engineering, product quality assurance and quality engineering to drive continuous process and product improvements.
REQUIREMENTS - QUALIFICATIONS: Quality Engineer
• Conduct all engineering activities in compliance with FDA Regulations, ISO 13485, MDD, CMDR, CMDCAS and other national and international quality and regulatory requirements and standards.
• Lead the product quality assurance and quality engineering aspects of activities to drive strong engineering and technical knowledge and application.
• Establish quality assurance, engineering programs, and initiatives to ensure products and assemblies are developed and manufactured in accord with applicable requirements.
• Conduct complaint investigations and provide corrective and preventive actions based on sound engineering analysis and review. Provide effective solutions that will drive continuous and measurable improvements.
• Work closely with Manufacturing/Operations, R&D and other departments to ensure highest quality products and processes are developed and deployed and are engineering sound. This includes product design testing, process testing, characterization, qualification, validation, risk analysis/FMEA, etc.
• Demonstrate solid understanding of internal and applicable external policies, procedures and standards.
• Develop systems for the identification, analysis, correction, and prevention of quality issues.
• Manage returned product analysis and failure investigation activities for manufactured products.
• Work with local regulatory compliance manager to ensure effective compliance to the product development protocol and other applicable systems.
• Participate in projects as assigned including operations and/or R&D projects.
• Communicate issues and opportunities to manager.
• BS in Engineering or related field.
• Knowledge of GMP, ISO 13485 and MDD, CMDR, CMDCAS
• Customer Focused Quality Process Improvement
• Minimum of three (3) years experience in highly regulated field.
• Verbal/written communication skills.
• PC skills.
• Quality Engineering statistical tools.
• Project management.
• Strong problem solving skills.
• Presentation skills.
• Effective interpersonal skills.
Medtronics
Back To Results
Apply to this job!
View Company Jobs
Free Career Test
Your Resume on 75 Job Sites
|
The goal of CareerTopJobs is to help candidates find
jobs more easily, like the job listed on this page, "Quality Engineer, in Santa Ana, California - Medtronic". We hope CareerTopJobs will become your job source for finding open job positions in the
Biotechnology and
Pharmaceutical industry job market.
