Product Quality Engineering Manager presso Neurologica

Product Quality Engineering 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:The Product Quality Engineering Manager leads a team of engineers and technicians responsible for daily quality control operations & continuous improvement of product quality for Computed Tomography imaging systems.

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

Define, optimize, implement & maintain testing strategy for sub-assemblies and system-level testing for finished Computed Tomography products

Define, optimize & maintain documentation for incoming inspection, assembly procedures, test procedures, capital equipment specifications and production tooling specifications

Plan & execute system and software verification and validation for design changes, new product releases and continuous improvement

Manage daily product quality operations such as incoming inspection, in-process testing, review and verification of product labeling, and final product acceptance & release for shipment

Generate appropriate metrics to quantify product quality & drive continuous improvement

Investigate and document non-conformances, deviations, and product defects both in production & the install base.  Lead root cause analysis and implementation of corrective actions

Maintain analysis of failing components, subassemblies and other issues in production & the install base.  Drive actions to deliver measurable product quality improvements across the Computed Tomography product portfolio.

Coordinate external safety testing for changes at system level, critical components and end of life parts

Provide subject matter expertise to ensure deviations, CAPAs, product validation, equipment calibration, facility controls and change management meet regulatory requirements and industry practices

Support quality department initiatives to meet corporate goals and objectives and ensure compliance with medical device regulations

Support preparation of field action documentation and executing the field action process

Support procurement in monitoring component obsolescence; identify alternate/substitute parts to maintain supply continuity.  Plan & execute verification and validation necessary to support part obsolescence change management.

Attend/complete all required training and follow all company policies regarding travel, expenses, meetings, and meals

Perform other duties and functions as needed by Management

REQUIRED SKILLS & ATTRIBUTES

B.S. in Engineering required.  Mechanical, Electrical or Mechatronics Engineering degree preferred

7+ years of experience in manufacturing or service of electro-mechanical or other complex systems

Proven problem solver & clear thinker.  Skilled in leading teams and motivating staff to deliver exceptional results within a predictable timeline

Communicate clearly (written and oral) with other company personnel, vendors, regulatory agencies, auditors and customers.

Flexible: able to follow directives and accomplish tasks outside of normal duties 

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

Proficiency with MS Office Suite (Excel, Word, PowerPoint, Outlook, etc.)

BENEFICIAL SKILLS & ATTRIBUTES

Strong technical understanding of imaging system performance testing and regulatory compliance

Knowledge of Medical Device Regulatory & Quality Standards for the following:

ISO 13485 / MDSAP / EU MDR

IEC 60601-1 standards for Medical Devices safety, EMC and usability requirements

ISO 14971 Risk Management requirement

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  

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