- Determines quality and reliability standards by studying drawings and formulas; verifying specifications with engineering staff.
- Identifies in process product condition by collecting samples during production process; conducting in process inspections and first article approvals. Works with operators and supervisors on quality policies and procedures; assists in training of employees on new policies and procedures.
- Determines acceptability of rework by conducting inspections and physical tests of reworked product.
- Documents finished product status by recording and summarizing raw materials, in process, and finished product inspection and physical test data; updating quality assurance data base.
- Maintains product quality documentation system by writing or rewriting quality assurance procedures.
- Maintains quality assurance operations by following quality assurance policies and procedures; reporting needed changes.
- Assist production manager with setting up jobs for production, including gathering all documentation and tooling as required.
- Responsible for product inspection and/or audits of quality control programs.
- Perform packing line and manufacturing inspection.
- Perform sampling and testing of components, materials, and equipment.
- Ensure that raw materials and products meet company standards.
- Determine methods, sequences, and procedures necessary for inspection.
- Interpret manufacturing drawings, diagrams, and specifications to approve or reject units or systems.
- Adapt measuring devices and procedures.
- Apply approval or rejection labels to raw materials once analytical data is evaluated.
- 2 - 4 years in medical device quality assurance or related field.
- An understanding of FDA Quality System regulations.