Quality Control Manager

Quality Control Manager WHO WE ARE:

Neuro Logica Corp., a subsidiary of Samsung Electronics Co. Ltd., develops, manufactures, and markets innovative imaging technologies and is committed to delivering fast, easy, and accurate diagnostic solutions to healthcare providers. Neuro Logica is the global corporate headquarters and manufacturer of mobile computed tomography, and is also the US headquarters for sales, marketing, service and distribution of all Samsung digital radiography and ultrasound systems.

Our advanced medical technologies are used worldwide in leading healthcare institutions, helping providers enhance patient care, improve patient satisfaction, and increase workflow efficiency. Samsung is committed to being a leader in the field of healthcare imaging.

Samsung is a growing presence in the radiology field and is committed to delivering fast, easy and accurate imaging solutions to healthcare providers. In 2015, Neuro Logica became the US headquarters for all of Samsung Health and Medical Equipment. The full range of Samsung imaging solutions includes Ultrasound, Digital Radiography, and mobile Computed Tomography (mCT). Samsung aims to become a global leader in the medical imaging space and is investing heavily in developing innovative, advanced imaging technologies that will improve the quality of people's lives.

Samsung keeps a constant eye on the always-evolving, ever-changing imaging industry. By continually enhancing current product lines and seeking to develop new technologies, Samsung is at the forefront of the imaging frontier.

Responsible for inspection, testing and process improvement to ensure high quality computed tomography medical imaging products and compliance with regulatory standards and guidelines.

• Manage daily QC operations including in process checks during manufacturing and final release of imaging systems
• Responsible for QC testing including (system and software) verification and validation for design changes and manufacturing improvement
• Investigate and document nonconformances, deviations, and product defects; lead root cause analysis and corrective actions
• Define, maintain, and improve QC documentation and processes to meet U.S. FDA 21 CFR 820 (FDA QMSR), MDSAP, EU MDR, ISO 14971 and ISO 13485 requirements
• Testing for sub-assemblies and system level testing for finished products
• External safety testing for changes at system level, critical components and end of life parts
• Generate appropriate metrics to quantify product quality including maintaining analysis of failing components, subassemblies and other issues.
• Facilitate failure analysis and field defect analysis along with trending information
• Serves as a liaison for providing quality engineering expertise for continuous process improvements for the engineering, service and manufacturing personnel
• Review and verify product labeling
• Work with and respond to, inquiries from regulatory agencies and assist with audits and inspections
• Contribute directly or manage designee to product ship reviews
• Direct the Incoming Inspection process of first articles, populated board assemblies and cable assemblies
• Provide subject matter expertise to ensure deviations, CAPAs, product validation, equipment calibration, facility controls and change management meet regulatory requirements and industry practices
• Assist with initiatives in the quality department to order to meet corporate goals and objectives and ensure compliance with medical device regulations
• Perform other duties and functions as needed by Management
• Assist with preparing field action documentation and executing the field action process
• Promote teamwork and collaboration within the quality function and with other functional areas
• Facilitate risk management activities (RMF, Risk/Benefit, planning, etc.) as deemed needed for all products to ensure compliance with regulating bodies
• Ability to create updates for Management Review Meeting
• Communicate clearly (written and oral) with other company personnel, vendors, regulatory agencies, auditors and the customer as required

• Bachelor’s in Engineering, Quality or related field preferred
• 7+ years of related experience in the Quality Control / Quality Assurance, with 3+ years in a leadership role in the medical device or imaging industry.
• Strong knowledge of ISO 13485 / MDSAP / EU MDR
• Strong technical understanding of imaging system performance testing and regulatory compliance
• Familiarity with IEC 60601-1 standards for Medical Devices safety, EMC and usability requirements
• Expertise in the use of Risk Management requirements via ISO 14971
• Ability to communicate effectively with engineers, assemblers, and management through all media
• Skills and expertise for creating, revising SOPs and providing employee training.
• Technically savvy; must be able to discuss, understand and make decisions regarding a wide array of engineering disciplines and complex technical/logistical issues
• Excellent…