Manufacturing Warehousing / Industrial Software
- Job Level:
We are currently seeking a Quality Inspector who will be tasked with performing inspections to ensure the quality of medical products manufactured.
Shift: Monday - Friday 7am - 3pm; Overtime mandatory on Saturdays after training.
- Performs Quality control inspections.
- Evaluate and organize quality system documentation.
- Read blueprints. Analyze and apply drawing requirements in various inspection and test situations.
- Determine 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.
- Apply Calibration Procedures (Gage traceability, Calibration status, Report calibration discrepancies, etc.)
- Assist other areas of the department as requested and/or needed.
- Networking/Key relationships: This position requires cooperating with different company departments, such as R&D, Logistics, Manufacturing Engineering and the other team members of the department.
Experience & Skills Required
- At least one (1) year as an inspector in a regulated industry (Medical Device or Pharmaceutical Manufacturing environment) or equivalent educational experience.
- 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
- Good knowledge and understanding of quality system regulations (e.g. 21CFR820, ISO 13485), Quality Standards, Requirements, and Specifications.
- Understand the concept of Customer and Supplier, both internal and external.
- Able to work independently.
- Ability to read Company’s procedures, engineering drawings and interpret requirements.
- Organizational and record keeping skills
- Must be able to communicate in English (oral and written)
- Must be able to interact professionally with all levels of personnel within the company.