Job Accountabilities:

• Serve as the primary quality assurance resource to department supervisors for problem identification, resolution, loss reporting, and continual improvement.
• Effectively communicate significant issues or developments identified during quality assurance activities and provide recommended process improvement.
• Responsible for customer complaint processing and resolving quality concerns.
• Lead investigations on returned product to identify root cause of failure.
• Collaborate with design and operations to identify and implement changes to address field returns.
• Initiate and manage CAPAs. Lead investigations on product to identify root cause of failure and recommend suitable corrective and preventive actions.
• A subject matter expert in Quality Engineering with skilled expertise in multiple Quality Engineering methodologies.
• Demonstrated risk-based decision-making skills including being able to navigate ambiguity. Understands risk in the application of controls and mitigations to ensure business objectives are met.
• Document investigations in compliance with FDA QSR so design improvements can be made.
• Supplier inspections and testing of received materials, parts, and products to ensure adherence to standards and requirements.
• Supports and provides technical expertise to many Quality processes, including Supplier Management, Product Quality Reviews, Change Control, Calibration, Preventive Maintenance, Equipment Controls, and other processes where out of specification, unexpected excursions, or corrections are encountered.

Core Competencies:

• Knows the Business:
  • Communicates effectively with customers to understand their unmet needs and envision products and services that will address those needs.
  • Maintains an understanding of assigned domains of expertise and shares significant new information with others in the company to identify strategic opportunities and anticipate threats to the business.
  • Educates others in strategic business vision, goals, and objectives, and helps others to understand how changes in the industry impact our business.
• Promote Teamwork:
  • Assesses the capabilities, intellectual capacity, and working styles of individuals in order to assemble cohesive and highly productive teams.
  • Able to assemble effective cross-functional groups to solve difficult problems and accomplish challenging objectives.
  • Provides the necessary guidance and support to ensure that teams function effectively.
• Communication:
  • Creates a climate of openness in which ideas are exchanged for the benefit of the organization.
  • Ensures that employees and contractors are well informed of key issues and needs in order to maximize engagement.
  • Effectively models and builds a culture of continuous learning.
• Manage Execution:
  • Creates an environment that enables effective execution and high-quality product and service delivery throughout the organization.
  • Achieve balance between short-and long-term priorities when making decisions in order to achieve company objectives.
• Drive, Innovation, & Change:
  • Able to create new technology and ideas that provide innovative solutions to customer problems.
  • Develops solutions that are “Cutting Edge” new to the industry.

Qualifications and Expected Functional Competencies:

• Bachelor’s degree with 5+ years related experience in a production environment executing nonconforming product and/or returned product investigations.
• Ability to apply critical thinking and creativity to problem solving.
• Strong knowledge of computers, computer applications, and electronic instrumentation.
• Understanding of statistical techniques, data management, investigation techniques, and technical writing.
• Passionate about quality.
• Experience and knowledge of FDA QSR quality system.
• Strong quality mindset, and ability to identify quality-focused continuous improvement opportunities.
• Anticipated travel: up to 15%
• Performs other related duties or special projects as assigned by management.

Desired Functional Competencies:

• Strong knowledge of electronics is a plus.
• Experience with identifying and implementing process and design changes to address quality and reliability issues.