Qa Design Transfer Engineer I/ii - South Jordan, Ut
Merit Medical Systems
South Jordan, Utah, United States
Not specified; not specified; benefits include med...
Onsite
Bachelor's degree in engineering
21 cfr 820 quality systems knowledge
Iso 13485 and iso 14791 standards
Merit Medical Systems is seeking a Qa Design Transfer Engineer I/II to provide quality engineering support for medical device products and processes in South Jordan, Utah. The ideal candidate will have a background in engineering, experience in quality systems for medical devices, and knowledge of regulatory standards
Job Summary
The role involves providing quality engineering support to ensure products are designed, tested, and manufactured in compliance with all applicable agency and internal quality requirements.
Candidates will be responsible for coordinating process risk analysis, leading risk management meetings, and ensuring the creation of Device Master Records.
Merit Medical offers a comprehensive benefits package including medical/dental insurance, onsite clinics, cafeterias, and a 401K plan.
Matching Summary
Match Score: 85
Merit Medical Systems is seeking a Qa Design Transfer Engineer I/II to provide quality engineering support for medical device products and processes in South Jordan, Utah. The ideal candidate will have a background in engineering, experience in quality systems for medical devices, and knowledge of regulatory standards.
Salary
Not specified; Not specified; Benefits include Medical/Dental, 401K, Vacation, Sick-Time, Paid Holidays
Skills & Requirements
Must-have
Bachelor's Degree in Engineering
21 CFR 820 Quality Systems knowledge
ISO 13485 and ISO 14791 standards
Process Validation and Test Method Validation
Root cause investigation and corrective actions
Engineering Change Notifications (ECNs)
Statistical methodologies and Six Sigma
Nice-to-have
Minitab and Oracle software experience
ASQ Certified Quality Engineering exam
Medical device industry background
Leadership and mentoring capabilities
Lean manufacturing principles
Continuous improvement initiatives
Teamwork and conflict resolution skills
Key Requirements
Bachelor's Degree in Engineering or related field
Working knowledge of 21 CFR 820, ISO 13485, ISO 14791
Experience with statistical methodologies and Six Sigma
Knowledge of regulatory agency regulations
Demonstrated computer skills in spreadsheets and databases