Quality Engineer

Quality Engineer

LOCATION: Draper, Utah

SCHEDULE: Standard

DURATION: 9-Month Contract

PAY: $37-42/hr

Job Responsibilities:

In this role, you will manage and support a variety of projects within the Quality Engineering department. Key responsibilities include:

• Leading multiple quality-related projects, including:
  • Investigating customer complaints for medical devices.
  • Analyzing manufacturing processes and data.
  • Implementing corrective and preventive actions (CAPAs).
  • Driving continuous improvement in product quality and compliance.
• Ensuring compliance with applicable quality standards and regulatory requirements for medical devices.
• Collaborating with cross-functional teams and stakeholders to ensure project success.

Essential Duties and Job Functions:

• Perform thorough investigations of customer complaints, providing detailed analysis of processes and data.
• Execute complaint investigations using a multifunctional, systematic approach.
• Oversee all phases of complaint investigations, ensuring timely completion.
• Collaborate closely with investigation owners to resolve issues and address overdue cases.
• Verify that complaint investigations are adequate and comply with applicable procedures.
• Apply quality engineering principles to ensure regulatory compliance and optimize product development, manufacturing, and distribution processes.
• Investigate moderately complex manufacturing quality and compliance issues across all production processes.
• Optimize manufacturing processes using engineering methods like Six Sigma, Lean, and TOPP.
• Develop and maintain technical content of risk management files, including pFMEAs.
• Create training and documentation materials for production processes and work instructions.
• Assign and coordinate tasks for technicians, providing guidance, training, and feedback.

Knowledge & Skills:

• Strong documentation, communication, and interpersonal skills.
• Basic understanding of statistical techniques.
• Experience working with laboratory or industrial equipment.
• Solid understanding of engineering principles, theories, and concepts.
• Strong problem-solving, organizational, analytical, and critical thinking skills.
• Thorough understanding of processes and equipment used in assigned work.
• Knowledge of and adherence to quality systems.
• Meticulous attention to detail.
• Ability to interact professionally with all organizational levels.
• Capability to manage competing priorities in a fast-paced environment.
• Proficiency in teamwork, including vendor and stakeholder management.
• Ability to build productive internal/external working relationships.
• Adherence to all company rules and requirements, including safety protocols.
• Proficiency with engineering software and computer applications, such as CAD.

Education & Experience:

• Bachelor’s degree in Engineering required.
• 2-4 years of relevant experience.
• Experience in the medical device industry preferred.
• Familiarity with quality systems and regulatory requirements for medical devices is highly desirable.
• Certification in quality engineering (CQE) or a related field is a plus.

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