Quality Engineer II

Job Title: Quality Engineer II
Location: Salt Lake City, UT
Duration: 12 Months
Shift: Monday - Friday | 8:00 AM - 5:00 PM
Pay Range: $35.00 - $38.00/hour on W2
Position Summary
The Engineer II, Quality - Complaints is a product quality representative that provides hands-on technical quality engineering support to product complaint investigations for multiple manufacturing facilities. Provides guidance to the manufacturing sites Quality and Operations teams, ensuring that investigation findings are appropriately addressed.

This position will also have direct interaction with customers and Global Field Sales representatives. Customer conference calls and visits may be conducted to better understand product issues, identify customer concerns before issues become complaints, and communicate on behalf of the Quality organization.

Responsible for the accomplishment of established quality goals. The Engineer II will complete intermediate projects with guidance from more experienced engineers and managers, gain exposure to complex tasks within the job function, and occasionally work independently on assigned responsibilities.
Essential Duties & Responsibilities

• Be a product expert, including product design, manufacturing processes, failure modes, and field applications.
• Process and investigate medical device customer complaints accurately and efficiently in a fast-paced environment.
• Prepare detailed and timely investigation reports.
• Provide quality support and communicate customer experiences and complaint findings with manufacturing sites.
• Collaborate with Quality, Engineering, Operations, and manufacturing teams to support ongoing CAPA investigations and product quality improvements.
• Contact U.S. customers to address ongoing issues, identify potential concerns, and provide updates on quality initiatives.
• Analyze weekly and monthly complaint trends to identify potential product issues.
• Work effectively in a team environment while managing changing priorities and time-sensitive tasks.
• Perform standardized testing or coordinate functional testing as required.
• Handle returned contaminated medical devices safely in a controlled laboratory environment.
• Perform additional duties and special projects as assigned.
• Conduct independent analysis and develop practical solutions to engineering problems.
• Prepare detailed design specifications and technical documentation.
• Receive general project direction while collaborating with senior engineers as needed.
• Assist in training employees on documentation, equipment usage, laboratory techniques, and departmental procedures.
• Communicate effectively with managers, peers, customers, and cross-functional teams.

Knowledge & Skills

• Experience supporting medical device products through FDA regulatory processes and Quality Management Systems (QMS).
• Experience writing product requirements, specifications, verification, validation, and traceability documentation.
• Ability to train and mentor team members.
• Experience using measurement and testing equipment.
• Strong troubleshooting and problem-solving skills.
• Proficiency with Microsoft Office (Excel, Word, databases) and statistical analysis tools.
• Excellent written and verbal communication skills.
• Knowledge of plastic processing and disposable medical device manufacturing.
• Good mechanical aptitude.
• Ability to safely handle returned contaminated medical devices.
• Understanding of engineering best practices and quality principles.
• Ability to contribute to product quality strategy.
• Ability to work independently while seeking guidance when appropriate.
• Strong decision-making and organizational skills.

Minimum Qualifications

• Must be at least 18 years of age.
• Bachelor's degree in Engineering, Technology, or another STEM discipline from an accredited institution.
• 2-4 years of relevant engineering or quality experience.
• Certified Quality Engineer (CQE) or Certified Reliability Engineer (CRE) certification preferred.
• Previous quality assurance experience preferred.
• Experience in a regulated manufacturing, medical device, pharmaceutical, or healthcare environment preferred but not required.

Work Environment

• Primarily a sedentary office-based role.
• Regular use of standard office equipment.
• Work is performed in a safe and professional environment.
• Requires handling returned contaminated medical devices in a controlled laboratory setting.
• Must occasionally lift or move objects weighing up to 15 lbs.
• Travel requirement: Less than 5%.