Medical Device Quality Assurance Specialist
4 days ago
Job Summary
The Medical Device Quality Assurance team at Lenmar Consulting Inc. is responsible for ensuring that all materials, processes, and activities related to medical device manufacturing meet current Good Manufacturing Practices (GMP) standards and comply with applicable procedures and regulations.
Key Responsibilities
- Inspect parts to specifications using measurement tools such as calipers, micrometers, gage pins, plug gages, and thread gages.
- Perform quality control checks on medical devices to ensure compliance with GMP standards and regulatory requirements.
- Enter acceptance data into the ERP system, SAP, and nonconforming material reports into the failure data system.
- Collaborate with cross-functional teams to resolve quality-related issues and implement process improvements.
- Stay up-to-date with industry regulations, such as ISO 13485 and ISO 9001, and ensure compliance with company policies and procedures.
Requirements
- Experience with material inspection and quality control in a medical device manufacturing environment.
- Proficiency in computer-based applications, including ERP systems and quality control software.
- Knowledge of optical measurement machines or Coordinate Measuring Machines (CMMs) is a plus.
- Familiarity with quality management systems, such as ISO 13485 and ISO 9001.
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