Quality Assurance Technician/ Inspector
9600 Jeronimo Irvine, CA 92618 US
The Quality Inspector is responsible for the inspection of the product at different levels of the process, including Receiving Inspection, First article inspection, In-process inspection, and Final inspection of all materials and products within the company, in order to assure that the material / product meets or exceeds the requirements set forth in Company documents and procedures. The responsibilities include material handling in support of production.
Duties & Responsibilities:
- Incoming Inspection, In-Process Inspection, First Article Inspection, Final Inspection, and/or Finished Goods Inspection and Acceptance Testing of parts/products;
- Generate and complete Quality Reports in accordance with released acceptance procedures, drawings, bill of materials, assembly master records, and device master records requirements;
- Perform functional testing per AP (acceptance procedures) and DR (drawing) requirements;
- Release / approval of labels printed internally;
- Review of work / job orders for compliance to internal documentation such as AMR (assembly master records), DMR (device master records), DR (drawings), and MB (bill of materials);
- Identification, segregation, and NCR generation for nonconforming products and materials;
- Keep up to date with document revision changes, as they affect all areas of inspection;
- Movement of material to designated locations in support of QC inspections, MRB, RMA, and Inventory processes. The material handling will include but not be limited to the physical movement of material in the warehouse and/or QC Areas, use of pallet jacks, packing and unpacking of material, palletizing material, lifting material, and verification of material quantities and documents;
- Performs other duties or special projects as assigned
- Five years of experience as a Quality Control Inspector/Technician (or similar role), within the medical device industry;
- Working knowledge of IPC-A-610 Solder Workmanship Specification;
- Knowledge of basic inspection tools (e.g. calipers, micrometers, height gages, etc.) and Mechanical Inspection;
- PC literate with good skills in MS Office (Word and Excel) programs;
- Working knowledge of GDP (Good Documentation Practices)
- Excellent verbal and written communication skills;
- Must be able to work with minimum supervision Preferred Qualifications:
- Prior experience with quality control systems;
- Familiar with Part 820 Quality Systems Regulation;
- Working knowledge of ANSI Y 14.5M Geometric Dimensioning and Tolerancing;
- IPC certification for IPC-A-610 Solder Workmanship Standards;
- Working knowledge of Vision / CMM inspection devices;
- Knowledge of Quality Systems Regulations, ISO 13485 standards;
- Familiar with GMP (Good Manufacturing Practices);
- Familiar with Agile, and Expandable ERP systems
High School diploma or GED is required. College degree is preferred.
Meet Your Recruiter
A native to Orange County, Nina’s staffing career began in 2006 placing quality engineering candidates with distinguished companies as a successful recruiter and client manager. Nina specializes in recruiting for mechanical and electrical engineers in all industries from aerospace, medical device and manufacturing. She understands the engineering programs and importance of matching specific technical skills for position success. Her strong connections within the industry have been vital in her success. Nina’s excitement in placing engineers is due to the direct impact the products have on people’s lives: Everything we touch has been engineered in one form or another. She currently works as an on-site manager at a prominent medical device company.
Outside of work, Nina has been a dedicated volunteer to local nonprofit organizations for the past 15 years. She also enjoys being outdoors, hiking and spending time with her three children.