Sr. Quality Assurance Technician/Inspector
Fort Lauderdale, FL Posted: 5/7/2021
Job: Sr. QA Technician/Inspector
Location: Sunrise, FL
Role: We are looking to hire a Sr. QA Technician/Inspector to assist our client (a global medical device company) in the review and revision of quality system documentation, inspection of products, measuring process performance, recording data, preparing formal reports, and analyzing quality problems.
Job Expectations include:
- Serves in the leadership role for QC inspection team.
- Independently manages special projects (e.g., validations/revalidations) or systems (e.g., non-conforming materials, sterilization, environmental monitoring)
- Assists QA engineering / QA manager in the execution and coordination of new product engineering development activities in areas related with packaging development, sterilization validation development, etc.
- Trains junior level inspectors as required.
- Performs quality control inspection as needed in periods of high production volumes or low manpower availability.
- Analyzes quality data, develop conclusions, and prepare reports for management.
- Read blueprints. Analyze and apply drawing requirements in various inspection and test situations.
- Determines sample size, selection method and accept/reject criteria for specific situations. Use related terms and concepts such as AQL, lot size, sample size, acceptance number, switching rules, sampling plans, zero-defect sampling, etc.
- Coordinates the environmental monitoring process to ensure that QC inspectors and QC technicians perform all the necessary tests during the time required.
- Familiarizes with the calibration procedures gage traceability, calibration status, report calibration discrepancies, etc.)
- Sets and design test apparatus, fixtures, jigs, etc.
- Prepares inspection plans and inspection instructions if requested by Management.
- Assists in developing new processes by implementing Statistical Process Controls.
- Performs (as requested by management) random audits of manufacturing work areas and/or documentation; to ensure compliance to Good Manufacturing Practices and the Quality Management System regulation.
- Provides technical assistance to QA engineering personnel (i.e., processes setting adjustments, problem solving, equipment verification, prototype product testing and general training)
- Monitors and trends Bioburden levels for product sterilized with gamma radiation and coordinate the DQA (Dose Quality Audits) execution.
- Assist QA Manager and QA Analyst with the implementation of SPC (Statistical Process Control)
- At least five (5) years as an inspector/technician in a regulated industry (Medical Device or Pharmaceutical Manufacturing environment).
- At least 2 years of experience involving validation or qualification testing.
- Ability to use the following types of tools, and evaluate measurement results to determine conformance to specifications:
- Hand tools (e.g., calipers, micrometers, linear scales)
- Gages (e.g., pins, thread, custom gages)
- Optical tools (e.g., comparators, profiles, microscopes)
- Electronic measuring equipment (e.g., digital displays and output), etc.
- Familiarity with sterilization practices, microbiological methods (e.g., environmental monitoring, etc.), and product release controls.
- Good knowledge and understanding of quality system regulations (e.g., 21CFR820, ISO13485), Quality Standards, Requirements, and Specifications.
- Understand the concept of Customer and Supplier, both internal and external.
- Good understanding of Class 7 environmental monitoring of clean rooms
Founded in 1995, by Ron & June Stein and still family owned to this day, Principal Technical Services (PTS) was designed to meet a gap in the market. We provide people and tools to Energy & Infrastructure and Life Sciences companies that want to do more than just "fill a position".
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