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Quality Technician II

Innovative Career Resources & Staffing
Aliso Viejo, CA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

 

A Medical Device client in Orange County is looking to identify and hire a Quality Technician / Inspector.  The Quality Technician / Inspector will primarily be responsible for performing quality functions to support IS013485, FDA, CGMP, Quality System Regulations, management reporting, LDD/ LAL production/QA/QC, chemistry QA/QC, product release, in-process inspection, incoming inspection, quality process improvements for LDD, LAL, manufacturing transfer, and facility support.

 

The Quality Technician / Inspector will be responsible for, but not limited to:

  • Performing optical and mechanical inspections with optical comparator, LPS, OCT, Nanovea, interferometer, Spectro radiometer, radiometer, calipers, micrometers, visual inspection systems, microscope, Keyence, Confocal microscope, Smartscope, etc.
  • Reading, comprehending, and following documents related to manufacturing, inspection and quality systems for audits, compliance, and implementation.
  • Performing batch records review, in-process verification, and quality checks for LDD as required.
  • Auditing and approving production records.
  • Verifying production process via auditing/observation and testing.
  • Inspecting process output and product parameters against specifications.
  • Ensuring routine compliance with process steps and proper documentation of records.
  • Maintaining raw material lot information, monitor expiration date and quarantine inventory when materials are expired.
  • Performing incoming inspection on raw materials and incoming sub-assemblies/finished goods.
  • Collecting data for process, quality system, manufacturing quality and performance metrics and generate reports for management review.
  • Revising, writing, and formatting Quality System controlled documentation, including procedures, forms and engineering documents for LAL, incoming inspection, LDD, and chemistry.
  • Initiating, implementing and controlling Change Notifications and Engineering Change Orders for LAL, incoming inspection and chemistry as required.
  • Identifying non-conformances, deviations, non-compliance, lack of calibration etc. and proposing corrective actions to management.
  • Facilitating Manufacturing Review Board and supporting non-conformance decision process.
  • Governing and transacting materials physically and through electronic system.
  • Monitoring laboratory and engineering equipment to ensure compliance with preventive maintenance and calibration programs.
  • Performing laboratory notebook audits, inventory audits, and maintaining QA retains.
  • Taking initiative for the process improvements changes as related to manufactured components and finished products for LDD, LAL.
  • Assisting the Quality Assurance team with any ad hoc reports and assignments as required.
  • Performing incoming inspection and lot control activities of materials and parts.
  • Assisting Quality, Manufacturing and R&D groups in running validation, verification, and developmental studies, and defining processes.
  • Developing inspection techniques and transferring to production and everyday use.

 

Requirements:

  • Associate's degree (A.A.) or equivalent from a two-year college or technical school; six months to one year related experience and/or training; or equivalent combination of education and experience.
  • Experience within a Medical Device company.
  • Prior experience/ knowledge in optical and mechanical inspection techniques.
  • Experience in inspecting minute parts under microscope.
  • Basic understanding of inspection processes.
  • Prior experience of working in cleanroom environment and/ or medical device manufacturing is highly preferred.
  • Professional, responsible, energetic and accountable.
  • Excellent communication skills.
  • Intellectually curious and eager to learn.
  • Individual must be Quality oriented and possess a natural ability to pay attention to details.
  • Knowledge of Microsoft Word and Excel.

 

 

Company Description
e·thos: from the Greek word meaning Character; the characteristic spirit of a culture, era, or community as manifested in its beliefs and aspirations.

Founded in 2002 with the conviction that people are the engines of success, we believe that above all things character and integrity are critical to the success of any organization or career. These are two values that Innovative will never compromise, which in turn equates to our associates being placed into opportunities that can develop into a long term successful career paths, while at the same time our clients benefit from top-tier talent for proven, successful results.

Innovative Career Resources & Staffing

Why Work Here?
Innovative Career Resources & Staffing... Connecting great people, with great companies!

e·thos: from the Greek word meaning Character; the characteristic spirit of a culture, era, or community as manifested in its beliefs and aspirations. Founded in 2002 with the conviction that people are the engines of success, we believe that above all things character and integrity are critical to the success of any organization or career. These are two values that Innovative will never compromise, which in turn equates to our associates being placed into opportunities that can develop into a long term successful career paths, while at the same time our clients benefit from top-tier talent for proven, successful results.

Address

Aliso Viejo, CA
USA

Industry

Technology

Website

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