QA444
Located in Richmond Hill, GA
Pay: 19.00+
Job Full Description
Job Summary: The Quality Assurance Specialist will oversee the quality control procedures and ensure that medical equipment and devices are stored, handled, and distributed in compliance with industry standards and regulations. The position involves inspecting, testing, and verifying the quality of products, maintaining documentation, and ensuring adherence to safety protocols in the warehouse environment.
Key Responsibilities:
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Quality Control Inspections:
- Conduct regular inspections of incoming, stored, and outgoing medical equipment to ensure compliance with industry regulations and company quality standards.
- Perform visual and functional checks to detect defects, damage, or inconsistencies in the products.
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Compliance with Regulatory Standards:
- Ensure all activities are in compliance with regulatory requirements, including FDA, ISO 13485, and other relevant health and safety standards.
- Monitor and enforce good manufacturing practices (GMP) and good distribution practices (GDP) in all warehouse operations.
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Documentation and Record Keeping:
- Maintain accurate records of inspections, audits, tests, and quality control reports.
- Ensure proper labeling and documentation for all products, following traceability requirements.
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Product Handling and Storage:
- Ensure proper storage conditions for medical equipment, including temperature, humidity, and cleanliness requirements.
- Implement and enforce standard operating procedures (SOPs) for handling and storing medical equipment to prevent contamination or damage.
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Non-Conformance Management:
- Identify and report any non-conformances or deviations from quality standards.
- Assist in investigating root causes of quality issues and recommend corrective actions.
- Work closely with the warehouse team to implement corrective and preventive actions (CAPA).
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Training and Support:
- Provide quality assurance training to warehouse personnel regarding proper handling, storage, and quality standards of medical equipment.
- Support and advise warehouse teams on best practices for ensuring compliance with quality standards.
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Inventory Control and Auditing:
- Conduct regular audits of warehouse inventory to ensure products are in good condition and meet regulatory standards.
- Assist in cycle counts and stock rotation to minimize the risk of expired or defective products.
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Continuous Improvement:
- Suggest process improvements to enhance efficiency, quality, and safety in the warehouse.
- Participate in quality meetings and audits to identify areas of improvement in the warehouse operation.
Qualifications:
- High school diploma or equivalent required; a degree in a related field (e.g., Life Sciences, Engineering) preferred.
- Certification in Quality Assurance or related fields (e.g., ISO 9001, ISO 13485) is a plus.
- Previous experience in quality assurance, quality control, or warehouse management, preferably in the medical equipment industry.
- Knowledge of FDA regulations, ISO standards, and medical device compliance requirements.
- Strong attention to detail, analytical skills, and the ability to identify and resolve quality issues.
- Excellent communication and interpersonal skills.
- Ability to work in a fast-paced environment and manage multiple priorities.
Working Conditions:
- Warehouse environment with moderate physical demands.
- Occasional exposure to cleaning agents and other warehouse chemicals.
- May require lifting of moderate-weight equipment.
#SAVGA
Savannah, GA
3166
2 Park of Commerce Boulevard
Suite I
Savannah, GA 31405
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