To discuss more about this job opportunity, please reach out to Deepak Arya (LinkedIn URL - www.linkedin.com/in/deepak-arya-8a79aa22a/), email your updated resume at Email - deepak.arya@collabera.com or give me a call at (425)-298-1474. Thank you!

Pay rate: $25 - $27/hr.

Position Details:

Client: Medical Device 

Education: High School Diploma or GED required with 2-5 years of experience 

Location: Irvine CA 92614 (on-site) 

Job Responsibilities:

• Supports manufacturing and testing operations adhering to Good Manufacturing Practices and Good Laboratory Practices to satisfy regulatory requirements for receiving and inspection. 
• Performs all job duties in full accordance with the client and Technical standards and complies with Client Quality System (QS) requirements.
• Ensures parts are compliant for all parts going to the manufacturing floor and any parts going directly to the customer. 
• Completes tier 1 & tier 2 inspections to test inbound material that will be used to assemble complex medical devices:
• Tier 1 inspections: 
• Manual routine inspections utilizing hand tools such as calipers, gauges (ring, pin, thread, height), rulers as well as visual inspections to test inbound material that will be used to assemble complex medical devices. May operate upper-level instrumentation. 
• Tier 2 inspections: 
• Operate advanced upper-level instrumentation: 3D/2D Digital Measuring projector and/or Optical Testing and Visualization Instruments (e.g. Optical Gaging Product (OGP), Keyence IM, etc.) 
• Performs inspection on printed material (e.g. Primary and Secondary labeling; manuals; print inserts; CD’s; etc.). 
• Accepts and rejects supplier lots based on inspection results.
• The information gathered is used by others to make both critical and strategic decisions. 
• Documents the non-conformance or suspected non-conformance to standards (i.e. manufacturing documentation, material/ component specifications, operating procedures, and domestic/ international standards) through the identification of unsuccessful audits, the completion of required paperwork, system transactions, and affixing his or her mark (i.e. stamp, sign-off or signature). 
• Reviews applicable sampling plans and control plans to verify product and services conform to quality and other engineering and Quality Assurance requirements.  

Minimum Requirements:

• Previous experience in Quality performing inspection. 
• Experience with measurement equipment, hand tools, gages, pressure and force gage testing 
• Training in blueprint reading and experience with inspection sampling techniques 
• Knowledge of FDA, GMP, ISO 13485.