Product Quality Engineering Manager

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