Job Details

Quality Engineer - Plastics - Base Salary to 115k/year - Los Angeles, CA

• Our client, a Plastics Films Manufacturer, is seeking a Quality Engineer to join their team in Los Angeles, CA.
• In this role, the Quality Engineer will be responsible for the quality control of the manufacturing process and product design.

Responsibilities:

• Use statistical tools to facilitate design verification test and test method validations
• Lead Risk Analysis (FMEA-CA Design/Process) meetings and create final reports and actions requirements
• Perform analyses of failed material in order to determine the root cause of failure and implement appropriate corrective actions
• Work on new product transfers
• Participate in the qualifications and validations of product/equipment and processes
• Review and approve document changes as needed
• Assist R&D in test method development and conduct test method validation
• Participate on internal quality audits and develop quality systems in compliance with ISO certification
• Review and approve receiving inspection requirements and sampling plans for components
• Develop and improve QC inspection and testing method as needed
• Backfill quality review, QC testing, receiving inspection and product release activities as required
• Support the implementation of the validation strategy
• Assess, process and circulate protocols and final reports for review and approval
• Execute each phase of the validation to ensure adherence to the protocol requirements
• Report Protocol exceptions
  Liaise with scheduling and sales as required to ensure communication and documentation flow

Qualifications:

• Bachelor's Degree in related discipline
• Experience and Knowledge in Good Manufacturing Practices (GMPs) and Quality Systems and ISO-13485
• Experience with medical instrumentation and disposables, in a regulatory environment (i.e. GMPs, ISO9001, ISO13485, etc.)
• Proficient in knowledge of variety of testing equipment (including Introns, pin gages, snap gages, micrometer, caliper, etc.)
• Proficient technical writing skills and use of documentation programs (e.g. Office Windows, Excel, Access, Power Point, etc.)
• Working knowledge of fundamental quality and statistical tools including SPC, DOE, Six Sigma
• ASQ Certified Quality Engineer Preferred

Compensation:

• Base Salary to 115k/year
• Generous vacation + PTO time
• 401k match
• Health and Dental Insurance
• Life Insurance

Compensation:
$115,000 per year