BPI Medical ยท 1 month ago
Quality Control Inspector
BPI Medical is a rapidly growing company that values integrity, quality, and collaboration. The Quality Control Inspector will engage in quality control activities to inspect and verify adherence to medical industry quality standards, working independently and following established procedures.
Customer ServiceHealth CareHospitalityManufacturingMedical Device
Responsibilities
Conducting inspections and tests on incoming raw materials, components, and finished products to ensure they meet established quality standards and specifications
Performing visual inspections, measurements, and functional tests on medical devices to verify their compliance with applicable regulations and standards, such as ISO 13485 and FDA guidelines
Documenting inspection results and maintaining accurate records of quality control activities in accordance with regulatory requirements
Proficient in the use of mechanical inspection equipment; including micrometers, calipers, fixed gauges, optical comparator, CMM and other inspection measuring tools
Identifying and reporting non-conformities or deviations to appropriate personnel for investigation and corrective action
Participating in investigations of quality issues and working with cross-functional teams to determine root cause and implement corrective and preventive actions
Ensuring that inspection equipment and tools are calibrated and maintained in accordance with regulatory requirements and company procedures
Developing and implementing quality control procedures and work instructions to ensure consistent product quality
Collaborating with production staff and other stakeholders to address quality issues and drive continuous improvement
Participating in internal and external quality audits to ensure compliance with applicable regulations and standards
Communicating effectively with customers, suppliers, and other stakeholders on quality-related matters, including product quality, regulatory compliance, and quality system requirements
Qualification
Required
Conducting inspections and tests on incoming raw materials, components, and finished products to ensure they meet established quality standards and specifications
Performing visual inspections, measurements, and functional tests on medical devices to verify their compliance with applicable regulations and standards, such as ISO 13485 and FDA guidelines
Documenting inspection results and maintaining accurate records of quality control activities in accordance with regulatory requirements
Proficient in the use of mechanical inspection equipment; including micrometers, calipers, fixed gauges, optical comparator, CMM and other inspection measuring tools
Identifying and reporting non-conformities or deviations to appropriate personnel for investigation and corrective action
Participating in investigations of quality issues and working with cross-functional teams to determine root cause and implement corrective and preventive actions
Ensuring that inspection equipment and tools are calibrated and maintained in accordance with regulatory requirements and company procedures
Developing and implementing quality control procedures and work instructions to ensure consistent product quality
Collaborating with production staff and other stakeholders to address quality issues and drive continuous improvement
Participating in internal and external quality audits to ensure compliance with applicable regulations and standards
Communicating effectively with customers, suppliers, and other stakeholders on quality-related matters, including product quality, regulatory compliance, and quality system requirements