Quality Inspector

Responsibilities

• Conduct assembly line audits to verify proper equipment set-ups, availability and use of calibrated tools, and adherence to approved work instructions.
• Reinforce Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) with production personnel to ensure consistent compliance.
• Review each Device History Record (DHR) or production record for completeness, accuracy, and legibility, and ensure records are properly archived in accordance with Quality System requirements.
• Execute product release activities, including performing independent final inspections, completing sign-offs, and executing system transactions to authorize shipment of conforming assemblies.
• Evaluate nonconforming material, coordinate disposition activities, and document investigations and dispositions in line with Quality System requirements.
• Participate in assembly line validations by collecting objective evidence, documenting validation results, and supporting approval of validation activities.
• Maintain and update operator training records, ensuring personnel are qualified and documented as trained before performing assembly tasks.
• Issue quality alerts to production personnel in response to complaints and nonconformances to prevent recurrence and promote corrective action.
• Document process deviations and in-process changes and route them for applicable approvals in accordance with established procedures.
• Identify and communicate work instruction and process gaps, providing clear information to support continuous improvement initiatives.
• Support the evaluation and documentation of rework for assemblies, including product returns, in compliance with Quality System requirements.
• Perform first article inspections and verify sheet metal and other components using appropriate measurement tools such as calipers, micrometers, and gauges.
• Apply corrective and preventive action (CAPA) principles when supporting investigations and quality improvements.
• Collaborate with cross-functional teams such as Material Review Board (MRB) to manage nonconformance and disposition decisions.
• Use electronic systems, including ERP and inspection management systems where applicable, to record, track, and manage quality-related data and transactions.

Essential Skills

• 1–2 years of experience in a manufacturing environment, preferably in device assembly or a similar production setting.
• Ability to read and interpret blueprints and technical drawings.
• Proficient use of measurement tools such as calipers, micrometers, and gauges for inspection activities.
• Experience with sheet metal inspection and first article inspection.
• Knowledge of Material Review Board (MRB) processes and nonconformance management.
• Intermediate-level understanding of Geometric Dimensioning and Tolerancing (GD&T).
• Familiarity with Good Documentation Practices (GDP) and production record review requirements.
• Ability to conduct assembly line audits and final inspections in accordance with Quality System procedures.
• Proficiency with Microsoft Outlook and Microsoft Excel for communication, documentation, and data tracking.
• Understanding of corrective and preventive action (CAPA) concepts and their application in a quality environment.
• Strong attention to detail and ability to ensure completeness, accuracy, and legibility of quality records.
• Effective communication skills to issue quality alerts, provide feedback to production personnel, and document findings clearly.

Additional Skills & Qualifications

• Broad understanding of materials, manufacturing technologies, and production processes.
• Proficiency with electronic ERP systems for managing production and quality-related data.
• Experience with inspection management systems for tracking inspections and results.
• Exposure to Good Manufacturing Practice (GMP) environments and regulated quality systems.
• Experience participating in validation activities, including collecting objective evidence and documenting results.
• Ability to identify and communicate process and work instruction gaps to support continuous improvement.
• Interest in developing skills in electro-mechanical assembly inspection as the operation expands in this area.
• Capability to work independently while collaborating effectively with production, engineering, and quality teams.