Incoming Medical Devices Inspection Technician

Incoming Inspection Technician

As an Incoming Inspection Technician, you will be responsible for inspecting parts and materials purchased from suppliers to ensure they meet high-quality standards before being used in manufacturing medical devices. Acting as the gatekeeper for quality, you will verify that every component, from screws to electronic parts, complies with precise specifications and safety requirements, supporting the production of critical medical devices.

Key Responsibilities:

• Inspect incoming parts, materials, fixtures, tooling, and assemblies using precision tools and machines in accordance with approved procedures and specifications.
• Review supplier documentation (certificates and inspection data) to verify compliance with quality requirements.
• Use SAP software to track inspection activities and maintain up-to-date inventory records.
• Accurately document test data, organize and summarize inspection results, and prepare reports following Good Documentation Practices (GDP).
• Ensure inspection equipment is properly calibrated and undergoes preventive maintenance; take corrective action for any deviations.
• Participate in internal, ISO, and other quality audits and support continuous improvement initiatives for inspection processes and procedures.
• Initiate nonconformance reports for defective materials and assist operations with investigations and product disposition.
• Support qualification and validation activities, addressing issues and implementing corrective actions as needed.
• Communicate material and quality issues effectively to management and collaborate with internal and external teams to resolve problems.
• Maintain proficiency with inspection instruments and troubleshooting methods for routine and non-routine testing.
• Foster positive working relationships with co-workers, suppliers, management, and other stakeholders to promote teamwork and quality culture.
• Perform other duties as assigned by management.

Required Qualifications:

• Minimum 2 years of experience in quality inspection within a manufacturing environment, preferably regulated sectors such as automotive, aerospace, or medical devices.
• Associate degree or equivalent relevant work experience.
• Ability to read, interpret, and apply engineering drawings and blueprints; proficient in Geometric Dimensioning and Tolerancing (GD&T).
• Knowledge of metrology, materials, calibration, auditing, and inspection techniques.
• General understanding of ISO 9001, ISO 17025, Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP).
• Strong grasp of traceability principles for products, materials, and calibration.
• Experience with Coordinate Measuring Machines (CMM) is highly desirable.
• Strong communication skills, including written, verbal, and listening proficiency.
• Excellent organizational skills with the ability to multitask and prioritize workloads effectively.

Bottom Line: Your role is critical in ensuring that all incoming materials meet safety, accuracy, and quality standards before they are used in medical device manufacturing. This role requires technical expertise, precision, detailed record-keeping, and proactive problem-solving to maintain the integrity of medical products.