Quality Systems Engineer
29 Parker , . Irvine, CA 92618 US
Job Description
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
Recruiter
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.