Product Quality Engineering Manager

Product Quality Engineering Manager

• Location: Danvers, MA
• On-site 4 days/week with the opportunity to work remotely 1/day per week. Additional remote work days can be arranged in consultation with your manager for special circumstances.

Who We Are

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.

Key duties and responsibilities, 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
  • 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

Qualifications and Requirements:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Education & Required Skills

• 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.)

Preferred Competencies

• 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

Physical Requirements

• Regularly lift and /or move up to 25 pounds, frequently lift and/or move up to 50 pounds
• Frequently required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear
• 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

Benefits

We offer a comprehensive benefit package which includes:

• 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!

Inclusion and Diversity Statement: We are an Equal Opportunity Employer and value diversity at all levels of the organization. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other characteristic protected by applicable law. We are committed to providing reasonable accommodation to individuals with disabilities throughout the application and employment process. If you require assistance or accommodation, please contact Human Resources.

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