Quality Engineer I (Sustaining) jobs in United States
cer-icon
Apply on Employer Site
company-logo

Ortho Development Corporation · 1 month ago

Quality Engineer I (Sustaining)

Ortho Development Corporation is an orthopedic design, manufacturing, and distribution company located in Draper, Utah. They are seeking a Quality Engineer to apply engineering tools to ensure competitive products that meet customer expectations and comply with specified requirements in the medical device industry.

3D PrintingHealth CareManufacturingMedical

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

Qualification

Quality System RegulationsISO 13485Problem solvingRoot cause analysisASQ CertificationSix Sigma certificationBachelor’s degreeEngineering experience

Required

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

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

Company

Ortho Development Corporation

twittertwitter
company-logo
Ortho Development Corporation is a manufacturing company that designs orthopedic devices.

Funding

Current Stage
Growth Stage

Leadership Team

H
Hiroyuki Minamiya
CEO
linkedin
leader-logo
Greg Larson
President
linkedin
Company data provided by crunchbase