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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