Quality Engineer I (Sustaining)

Are you looking for a great work culture, good teammates, and caring leadership? Ortho Development is the place to be. We offer great benefits, working Monday through Friday. We are an exciting place to work. Ortho Development Corporation helps people do what they love by restoring mobility. We are an orthopedic design, manufacturing and distribution company located in Draper, Utah. We offer a complete benefits package, clean work environment, and thorough training.

As a Quality Engineer, you apply engineering tools to ensure Ortho Development delivers competitive products that meet or exceeds customer expectations and conforms to specified requirement. This full-time onsite position is a great opportunity in the exciting medical device industry.

Schedule: Monday to Friday

12:00 PM to 9:00 PM

Your Responsibilities

• Quality representative on design- and process-related product line project teams.
• Identify and mitigate patient risk and design- and process- related product line.
• Develop inspection plans and methods using sampling and metrology principles.
• Create procedures for inspction equipment and provide training.
• Manage supplier product line qualification/monitoring requirements throughout product lifecycle including initial production and process changes.
• Laison with suppliers regarding inspection methods and product line quality issues.
• Evaluation and disposition of nonconforming materials and products.
• Evaluation, investigation, and resolution of complaints.
• Develop and perform validation on quality equipment.
• Review / Approval of process- and product-related documents to ensure accuracy, regulatory compliance, and system/process/equipment integrity.
• Collect, trend, and analyze process data and report to upper management.
• Assist with supplier quality system audits, approval status log and performance metrics.
• Perform other job-related duties as assigned.
  
  

Requirements

• Bachelor’s degree
• Interpret inspection reports and compare with drawing requirements and geometric dimensions and tolerances.
• Problem solving and root cause analysis.
• Experience with Quality System Regulations and ISO 13485.
• ASQ (or similar) Certification
• Six Sigma certification
• Minimum of 0-2 years Engineering experience in medical device or related industry and Quality Engineering
  
  

Benefits

We offer competitive compensation and excellent benefits including:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discounts
• Flexible spending account
• Health insurance
• Life insurance
• Paid Holidays
• Paid time off
• Parental leave
• Tuition reimbursement
• Vision insurance
• Wellness incentives
• UTA Transit Pass