Quality Systems Engineer

Irvine, CA 92618

Employment Type: Contract Industry: Medical Device Job Number: 17329 Pay Rate: $34 - $ 39hr

Job Description

Medical Device Manufacturing Company in Irvine, CA is seeking an experienced Quality Systems Engineer.

Schedule: Starts at 6AM or 7AM

Job Type: Contract

Job Responsibilities
  • Analyzes nonconforming product, process, and material issues supported by use of root cause tools to drive corrective actions.
  • Completes QE disposition for RGA, NCMR, and CAPA.
  • Manages processing of internal NCMRs and/or complaints and participate in MRB and/or complaint review sessions.
  • Communicates with suppliers to address quality concerns and resolves issues
  • Conduct product investigation from product complaint returns and complete documentation using standard complaint handling system.
  • Fulfills document control and records requirements, such as completion of design and validation reports, and initiating change orders.
  • Maintains and develops processes and procedures by writing standard work instructions for operations involved with production and quality.
  • Maintains confidential company and supplier information.
  • Works with production operators and QC inspectors in production environment, as required.
  • Provide feedback to Quality, Operations, Engineering and R&D on quality issues.

Qualification Requirements
  • Bachelor’s degree in engineering or scientific field.
  • A minimum of 3 years of quality engineering experience supported by hands-on experience in medical device manufacturing with strong working knowledge of 21 CFR Part 820, ISO 13485 and EN ISO 14971.
  • Proficient with computer programs including MS Office programs.
  • Knowledge of Quality Systems for medical device manufacturing and requirements for inspection and testing.
  • Experience with documents (protocol and reporting) and product/process validations.
  • Initiates and/or verifies corrective and preventative actions resulting from NCMR's, audit findings and customer complaints.

Meet Your Recruiter

Erika Castro

Erika Castro is a recent graduate from Chapman University, where she majored in Sociology and minored in Latinx and Latin American Studies. As a Recruiter at Marquee Staffing, she specializes in manufacturing and production roles within the medical device industry. Her previous recruiting experience involved working for the state of California to fill open seasonal positions.

In her free time, Erika enjoys hiking the nearby hills, traveling to San Francisco and Mexico, and reading the newest book that has caught her interest.

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