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Quality Control Manager

Neurologica · Danvers, Vereinigte Staaten Von Amerika · Onsite

  • Senior
  • Optionales Büro in Danvers
Jetzt bewerben
Quality Control Manager
 
WHO WE ARE:
NeuroLogica 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. NeuroLogica 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, NeuroLogica 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.

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


ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned
  • 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


    • EDUCATION & EXPERIENCE
  • 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 written, oral, and documentation skills
  • In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire


    • COMPUTER & ANALYTIC SKILLS
  • Must be able to assemble facts from various areas, analyze data, and provide informed recommendations to management
  • Must be able to work with minimal supervision, take charge of projects, and work effectively in a demanding, fast paced environment
  • Must be excellent with technology, be able to present using a laptop computer, and be able demonstrate proficiency with MS Office package, including Excel, Word, and PowerPoint; as well as Outlook 


    • PHYSICAL REQUIREMENTS
  • Occasionally lift and /or move up to 25 pounds
  • Frequently required to sit; use hands to finger, handle, or feel; reach with hands; and talk or hear
  • Must be able to sit for long periods of time 
  • The noise level in the work environment is usually mild.
  • Specific vision abilities required by this job include Close vision, Distance vision, Peripheral vision, Depth perception and Ability to adjust focus
  • Interaction with x-ray devices; for this reason strict safety and tracking programs are in place, requiring the utilization of dose monitoring equipment either full time or as necessitated by situation


    • COMPETENCIES
  • High attention to detail
  • Understanding of terminology and ability to share and communicate effectively within the group
  • Ability to organize and prioritize tasks resulting in consistent productivity
  • Ability to function within and support a team environment and build strong working relationships
  • Dependable and punctual
  • Ability to meet accuracy and productivity goals.
  • Good problem-solving skills, ability to evaluate situation and prioritize factors in decision making
  • Self-motivated, utilize available resources for self-improvement and development
  • Flexible: able to follow directives and accomplish tasks outside of normal duties  


    • About NeuroLogica
     
    Located North of Boston in Danvers, MA, NeuroLogica Corporation, a subsidiary of Samsung Electronics, develops, manufactures and markets innovative medical imaging equipment for healthcare facilities and private practices worldwide.  As a fast-moving, entrepreneurial company, NeuroLogica is a rapidly growing presence in the radiology field and is committed to delivering fast, easy and accurate imaging solutions to healthcare providers.  We welcome you to learn more at: https://www.neurologica.com .

    We offer a comprehensive benefit package which includes;
    - 4 Different Blue Cross/Blue Shield Medical Plans to meet your needs
    - Dental coverage through BlueCross/Blue Shield Dental
    - Vision coverage by Blue Cross/Blue Shield
    - Company paid Short-term and Long-term Disability coverage
    - $1 for $1 401k match up to 5% managed by Fidelity
    - Other benefit options such as company paid employee life insurance, a wellness program, tuition reimbursement and many more! 

    NeuroLogica welcomes diversity and is an AA/EEO Employer – Minorities/Women/Veterans/Disabled and other protected categories are always encouraged to apply.