Quality Control Technician - I

Summary/Purpose of the Position:

The Quality Control Technician I is responsible for performing quality control reviews of purchased and/or manufactured products and records. This activity is executed in real-time and in accordance with the Quality System guidelines.

Essential Duties, Functions and/or Responsibilities:

• Performs incoming, first articles, in-process, final inspection, and re-work quality checks, using a wide variety of inspection tools.
• Determine product acceptance status after inspection.
• Identifies and escalates non-conformances observed during inspection.
• Follow Good Documentation Practices (GDP) during document review and inspection.
• Performs all work in compliance with company policy and within the guidelines.
• Ensures process compliance, as needed/required.
• Reviews and approves production batch records (i.e., Device History records).
• Releases work in process to finished goods inventory. Flags inconsistent or incorrect records and report errors to supervisors or the management team.
• Inspects products to specification or processes.
• Segregates non-confirming product and seeks guidance on reporting the non-conformance.
• Physically quarantines non-conforming products and seeks guidance on reporting the quarantined materials.
• Performs QC testing as needed.
• Exhibits competence with testing methods selected for assigned tasks.
• Maintains a safe and healthy work environment by following standards and procedures, complying with legal regulations.
• Reports Quality problems or concerns to direct reports or the quality manager.
• Populates databases for collection and analysis.
• Directly and indirectly responsible for product quality
• Other duties as assigned.