Quality Engineer

Title: Quality Engineer

Location: Bay Area, CA (100%onsite) or 50-50 if live in LA

Duration: 6 months

Hours per week: 40

Start Date: Immediate



Job Description

Our client is looking for a Quality Engineer (QE) to work closely with validation and quality to sign off on documentation and participate in risk assessments (including design, DFMEA and FMEA) and quality decisions. The site is working with Injection Molded Plastic Products; this experience is required. The resource chosen for this role will need to come from a senior-level background and display at least 10-15 years of experience in order to be able to drive efforts efficiently and effectively with minimal hand-holding. The site is lacking expertise in certain areas within Quality and it would be ideal if this person was experienced/established and knowledgeable overall. Tasks will involve communication with vendors and navigating through specific situations as they arise. In addition, the QE will be signing off on quality deviations, change controls, design controls, risk assessments, validation documentation, specifications and potentially engineering drawings.



There will be more of an onsite presence needed for the beginning of the project for the consultant to learn the process and the product. Once familiarity has been established, the role will be more remote-based with occasional travel.



Skills required:


Injection Molding Plastic Product experience
10-15 years in the FDA industry as a Quality Engineer
Broad knowledge of quality documentation, risk assessment, deviations, CAPAs, design controls, process validation, DOE, specifications, change controls and validation documentation
Excellent problem-solving, communication and organizational skills.




Plus/Nice to have (not required):


Background in Chemicals is not required; however, it would be beneficial for the client because injection molding tied to a chemical functionality will help them with an additional function.
ASQ CQE and/or CQA
Experience with operating and programming CMM (Coordinate Measuring Machines)
Metrology experience.

Skills : QUALITY ENGINEER , FMEA , QUALITY DOCUMENTATION