Job Responsibilities:

• 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.

Qualifications:

• 2 - 4 years in medical device quality assurance or related field.
• An understanding of FDA Quality System regulations.