The Senior Quality/Regulatory Engineer will own as well as contribute to the overall Quality Management System, apply the requirements to the processes, products or services, provide guidance for less experienced engineers and ensure compliance to applicable laws, regulations and standards.

You will actively participate in quality improvement endeavors while working collaboratively and cohesively with employees to resolve issues.

Ensure compliance with standards, certifications, identify issues, recommend solutions, and create quality documentation.

Skills include knowledge of ISO standards, problem-solving and attention to detail.

Experienced in reliability on full product lifecycle, from corrective actions during design to corrective actions after fielding equipment. Experience in reliability mitigations through preventative maintenance.

Experience in economic modeling of reliability as well as assessing economic impact of corrective actions for a CT scanner. Compare alternatives with economic assessment.

Model/Create MTBF for entire system using standard model (e.g., MIL-217) for large, complex electromechanical systems. Includes system plus all components MTBF/MTTR modeling. Employ model to predict annual service costs and create service standards.

Design in-house reliability tests, both at system and critical component level (e.g., detector aging).

HALT test development and execution experience on a security CT scanner components as well as ability to design/perform elemental engineering studies into failures to facilitate investigations and proper, data-based decision making. Ability to choose appropriate level of testing.

Assist or perform root cause failure analysis. Bridge from failures to design improvements. Ability to identify and suggest corrective action for process as well as equipment. Expert in CAPA.

Experience with security CT scanner operational reliability measurements. Work with field service (including distributors or 3rd party service) to create and maintain site reliability and performance metrics.

Work with suppliers to improve quality product and processes.

Design and write system reliability tests for CT scanner. Includes reliability, performance, IQ, etc.

Create quality and safety documentation, specifically for large complex electromechanical radiation producing equipment.

Develop incoming inspection tests, vendor tests, etc. for manufacturing.

Perform internal audits to assure process adherence by all groups.

Create, maintain and audit a database of project related documents.

Prepare documentation for regulatory approval and certifications.

Lead or participate in the development, implementation, compliance, and maintenance of standards (e.g., ISO 9001, ISO 14001, etc.) and procedures.

Minimum Education, Experience and Qualifications:

BS in engineering or related scientific discipline.

5 years experience as a quality/regulatory engineer.

Strong knowledge of relevant software, quality assurance methods, tools and quality manufacturing processes

Experience in formal reliability modeling.

Experience in EDS industry using transmission x-ray equipment.

Ability to function effectively as part of a team, while also being able to work independently.

Proficient in use of office software tools (MS Office, Open Office, or equivalent)

Excellent written, verbal, and interpersonal communication and teamwork skills

Willing to travel domestically and internationally (up to 20% travel).

Desired Qualifications:

MS preferred.

MBA

Experience commercializing products.

Experience with ISO and UL design safety standards.

Experience in economical modeling based on reliability models

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