Principal Manufacturing Quality Engineer -- Orange County Area CA. Sept. 13, 2009

Principal Manufacturing Quality Engineer -- Orange County Area CA
* Must have Medical Device Industry experience
* BA / BS degree preferably in engineering or equivalent.
* General knowledge in regulations, MDD, and ISO requirements.
* ASQ Certification (CQE) & Lean sigma training or certification.
* Minimum of ten years of industrial experience.
* Minimum five years management expertise in Class II or III Medical Device Industry.
* Experience in heart valves or highly regulated industry (Big Plus)

Position Description (brief summary of job purpose): 

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.

Position Responsibilities/Authority (in bullet form, describe the key accountabilities or deliverables of the position):

* 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 and educate use of quality engineering tools (Lean Sigma) within the organization to drive methodical approach to design and process development, implementation and improvement. Apply same approach to existing processes including utilization of new technologies. The tools include, but are not limited to, six sigma, analytical statistics, advanced statistical engineering, design of experiments, and other proven tools. 

* Develop systems for the identification, analysis, correction, and prevention of quality issues. 

* Manage returned product analysis and failure investigation activities for manufactured products.

Must be Local to this area!!!

Interested contact Harley Davis 888-355-4345
harley.davis@etgjobs.com