Product Quality Engineering Manager

Neurologica Corp • Danvers, MA

2d • Onsite

About The Position

NeuroLogica, a Samsung company, serves as the global headquarters and manufacturer for Samsung Healthcare’s Computed Tomography (CT) business, delivering innovative mobile CT solutions used in leading healthcare institutions worldwide. Our technologies help providers enhance patient care, improve satisfaction, and increase workflow efficiency across diverse clinical environments.

As part of Samsung Healthcare USA, NeuroLogica works alongside Boston Imaging to deliver Samsung’s full portfolio of imaging solutions, including Computed Tomography, Ultrasound, and Digital Radiography. Backed by the global strength of Samsung Electronics, we are advancing medical imaging at an unmatched rate of innovation, developing customer-centric solutions quickly and with passion to address the real challenges clinicians face every day.

Guided by a vision to make the world a healthier place, NeuroLogica empowers healthcare providers with technology that helps them diagnose more confidently, deliver care more quickly, and do so in a cost-effective way. By continually refining today’s solutions and accelerating the breakthroughs of tomorrow, Samsung Healthcare remains at the forefront of an ever-evolving healthcare landscape.

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.

Requirements

• 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.)

Nice To Haves

• Knowledge of Medical Device Regulatory & Quality Standards:
• ISO 13485 / MDSAP / EU MDR
• IEC 60601-1 standards for Medical Devices safety, EMC and usability requirements
• ISO 14971 Risk Management requirements
• Strong technical understanding of imaging system performance testing and regulatory compliance

Responsibilities

• 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
• Incoming inspection
• In-process testing
• Review and verification of product labeling
• 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

Benefits

• Medical (Blue Cross Blue Shield): 5 PPO Plans (with up to 95% employer contribution)
• Dental (Blue Cross Blue Shield): 2 PPO Plans (with up to 80% employer contribution)
• Vision (Blue Cross Blue Shield): 100% company paid
• Short/Long Term Disability, Life & AD&D (The Standard): 100% company paid
• 401k Retirement (Fidelity): 100% company match up to 5%
• Tax Deferred Health Care Savings Programs
• Accident Insurance, Critical Illness, Hospital Indemnity, Pet, Legal, ID Theft
• Generous paid time off, tuition reimbursement, and more!

What This Job Offers

• Job Type: Full-time
• Career Level: Manager