Urgent opening::::Quality Engineer:::Santa Ana, CA

Hi,

Note: More than 5 years of experience required.

Please review the following job description and if interested please share updated resume and best time to reach you.

Position: Quality Engineer - 46216

Location: Santa Ana, CA

Duration: 12 Months

Job Duties : Completes Design History File documentation ,Design of Experiments (DOE) and Statistical Process Control (SPC),Determines manufacturing operation requirements and process parameters ,Develops advanced manufacturing systems and processes, Develops plans to evaluate process repeatability and stability ,Develops product and process improvements, Participates in procedure writing and review ,Performs process and equipment validations ,Supports manufacturing, development, and implementation processes, Utilizes FMEA within process development ,Ensures compliance with GMP's, Generates documentation for engineering protocols and reports ,Writes engineering and manufacturing specifications

Required:

Education Level: Undergraduate Degree

Industry Experience: Greater than 5 Years

Written Communication: Good or Excellent

Desired:

Certifications/ Engineering: ASQC

PE - Professional Engineer

QS, 21CFR - GMP/QSR,

29/40CFR, title 8, and NRC Compliance

Written Communication: Legible Handwriting

Request Notes : .

· Supported New Product Development as a Quality Engr 2.

· Experience with a. NCMRs b.CAPAs c.Root cause analysis d.

· FMEAs- lead the update of an FMEA e.Preferred: Component qualifications .

· Preferred: manufacturing floor support g.creating/updating manufacturing procedures h.working in a cross-functional team 2 spots, need additional subs, bill rate now $90/hr 07/28/14 MP Masters preferred, not required. No potential for conversion/extension at this time.

· No OT anticiapted. Sr. Quality Eng w/ New Product Development experience.

· Education:

· BS degree in Engineering or related

· ASQ Certified Quality Engineer or Reliability Engineer.

· Knowledge of GMP, ISO 13485 & MDD, CMDR, CMDCAS

· Training in Customer Focused Quality & / or Process Improvement.

· Preferred Education:

· Certificate of Professional Engineer (PE) or MS Degree.

· Lean Sigma training or certification.

· Certified Quality Engineer (CQE)

· Certified Quality Auditor (CQA) Minimum:

· Five (5) years of experience in highly regulated field.

· Preferred :

· Five (5) years expertise in Class (II) or Class (III) Medical Device Industry.

· Position Description: Ensure products & assemblies manufactured in Orange County Operations meet specifications & are developed & manufactured w/ highest product quality & meet all applicable product quality, design & manufacturing process requirements.

· Provide leadership in areas of process engineering, product quality assurance & quality engineering to drive continuous process & product improvements. Position Responsibilities: •Conduct all engineering activities in compliance w/ FDA Regulations, ISO 13485, MDD, CMDR, CMDCAS & other national & international quality & regulatory requirements & standards.

· Lead the product quality assurance & quality engineering aspects of activities to drive strong engineering & technical knowledge & application.

· Establish quality assurance, engineering programs, & initiatives to ensure products & assemblies are developed & manufactured in accord w/ applicable requirements.

· Conduct investigations & provide corrective & preventive actions based on sound engineering analysis & review. Provide effective solutions that will drive continuous & measurable improvements.

· Work closely w/ Manufacturing/Operations, R&D & other departments to ensure highest quality products & processes are developed & deployed & are engineering sound.

· This includes product design testing, process testing, characterization, qualification, validation, risk analysis/FMEA, etc.

· Demonstrate & educate use of quality engineering tools (Lean Sigma) within the organization to drive methodical approach to design & process development, implementation & 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, & other proven tools.

· Demonstrate superior engineering thinking based on both driving business objectives & product quality improvements.

· Demonstrate solid understanding of internal & applicable external policies, procedures & standards. Develop systems for the identification, analysis, correction, & prevention of quality issues.

If interested revert with the following details:

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