Quality Engineer

Purpose

This role has responsibility to support day-to-day productions for Digirad brand systems, by developing, implementing, and maintaining quality standards and processes, and partnering and collaborating cross-functional teams (engineering, manufacturing, facilities, etc.) to address projects and issues that arise in the productions areas.

Primary Duties And Responsibilities

• Develops, modifies, applies, and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborates with other functions such as engineering and manufacturing functions to ensure quality standards are in place.
• Devises and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.
• Specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
• Support and lead, as assigned, Nonconforming Material Report, Corrective Action and Preventive Action (CAPA), Calibration discrepancy and other investigations utilizing quality tools such as DMAIC, 5-Whys, Ishikawa Diagram, Control Charts.
• Apply knowledge of process control tools, statistical sampling and other analytical techniques to maximize the quality and flow of product through the production line.
• Identify, analyze, and manage risk through product life cycle with use of FMEA and other risk management tools.
• Troubleshoot equipment, process or material issues and provide resolutions.
• Support projects to support the site manufacturing and quality improvement initiatives.
  
  

Physical Demands

• While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; talk or hear; taste or smell
• The employee must occasionally lift and/or move up to 25 pounds
• Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
  
  

Working Conditions

• Work can be performed in a semi-quiet office setting and a noisy warehouse setting. The position involves computer and phone work.
  
  

Occupational Exposure

• Work environment may involve exposure to potentially dangerous materials and situations that require following extensive safety precautions and may include the use of protective equipment.
• Work involves moderate exposure to unusual elements, such as extreme temperatures, dirt dust, fumes, unpleasant odors, and loud noises.
  
  

Occupational Accomodations Statement

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Bachelors degree in Engineering or Science related field required.
• 2 years related experience with working in a QMS environment; FDA regulated facility; Basic knowledge under ISO 13485 and ISO 14971 standards.
• Must complete compliance training upon hire and annually thereafter including OSHA Safety, HIPPA compliance, incident reporting, workplace bullying and sexual harassment.
  
  

This description incorporates the most typical duties performed. It is recognized that other related duties not specifically mentioned may also be performed. The inclusion of those duties would not alter the overall evaluation of this position.