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Quality Engineer, Neil Med, Santa Rosa, CA. Oct. 8, 2009
Quality Engineer, Santa Rosa, CA
JOB TITLE: Quality Engineer
DEPARTMENT: Quality Assurance
Location: Santa Rosa, CA
Company: Neil Med, www.neilmed.com
MAIN PURPOSE OF JOB:
Leads quality activities to support the lifecycle of the product.
Develops, evaluates, and implements protocols/ methods to inspect and
test in-process raw materials and finished while ensuring they are in
compliance with both company quality assurance standards and applicable
government regulations. Maintains knowledge of new developments and
technology. Monitors products, processes, and projects within assigned
product line and recommends changes to improve operating efficiency and
quality.
MAIN JOB DUTIES/RESPONSIBILITIES:
• Ensures compliance to in-house and external specifications and
standards, such as current Good Manufacturing Practices (cGMPs) and
International Organization for Standardization (ISO) regulations.
• Performs analysis and identifies trends in inspection of
finished products, in-process materials, and bulk raw materials, and
recommends corrective actions and process improvements.
• Performs analysis and identifies trends in product field
performance and recommends corrective actions and process improvements.
• Evaluates and analyzes the efforts in organizing, documenting,
and interpreting inspection support documents and records.
• Ensures that established manufacturing inspection, sampling and statistical process control procedures are followed.
• Represents quality on various business teams to support product and process improvement.
• Represents quality during protocol development that ensures
products and processes are designed, developed, transferred, and
commercialized to meet appropriate regulations and business outcomes.
• Contributes to the definition of quality system policies.
• Performs other related duties as assigned.
REQUIREMENTS
KNOWLEDGE / EDUCATION
• BS in Engineering or equivalent
• Knowledge of QSR / ISO13485 / EN 46002 / MDD
• Preferred green belt or six sigma
JOB EXPERIENCE
• At least 2 years experience
SKILLS/COMPETENCIES
• Audit skills
• Statistical Knowledge
• Supervisory /Management skills.
• Communication, technical writing
PHYSICAL REQUIREMENTS
May require domestic and international travel (10-20%)
If Interested please mail your CV with current salary and expected salary and joining period to raghavan@vie-solutions.com ASAP
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