Overview
Quality Engineer Jobs in Midvale, Utah, USA at The Ranger Group
Job Summary:
We are seeking a highly motivated Quality Engineer with experience in medical deviceprocess validation to support New Product Introduction (NPI) activities. The ideal candidate will have a strong understanding of quality engineering principles, validation requirements, and regulatory expectations under ISO 13485 and FDA 21 CFR 820.
Key Responsibilities:
Participate in cross-functional NPI teams to ensure quality requirements are integrated into design and manufacturing processes.
Develop and execute risk management activities including Process Failure Mode and Effects Analysis (PFMEA)
Author and/or review validation protocols and reports for Test Method Validation (TMV), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Support the design and execution of process validation and capability studies to ensure robust, repeatable, and compliant manufacturing processes.
Collaborate with R&D and Manufacturing Engineering to define critical-to-quality characteristics and establish control plans.
Ensure supplier quality by reviewing and approving validation documents, conducting audits as needed, and working with suppliers to resolve quality issues.
Contribute to the development of quality plans, inspection methods, and procedures to ensure compliance throughout the product lifecycle.
Maintain documentation in accordance with internal procedures and external regulatory requirements (ISO 13485, FDA QSR, MDR as applicable).
Required Qualifications:
Bachelors degree in Engineering, Life Sciences, or related field.
3+ years of experience in quality engineering within the medical device industry.
Demonstrated experience with NPI, process validation, and test method validation.
Working knowledge of IQ/OQ/PQ, PFMEA, and supplier quality processes.
Familiarity with GMP, ISO 13485, FDA 21 CFR 820.
Strong communication and documentation skills with an ability to work cross-functionally.
Pando Logic. Â /
Quality Assurance
Engineer,
Location:
Midvale, UT – 84047 , PL:
Title: Quality Engineer
Company: The Ranger Group
Location: Midvale, Utah, USA
Category: Engineering (Quality Engineering, Biomedical Engineer, Process Engineer), Quality Assurance – QA/QC (Quality Engineering)
