Loading, Please wait..!!
Quality Engineer
-
Posted on: Oct 28, 2026
-
Salt Lake City, Oklahoma
-
Onsite
-
Full-time
Curious about compensation?
Explore the historical salary trends, average pay, and estimated compensation for Quality Engineer roles in Oklahoma.
View Salary Guide →Find your match !
Job Title :
Quality Engineer
Job Type :
Full-Time
Job Location :
Salt Lake City Oklahoma United States
Remote :
No
Job Description :
Job Description
We are seeking an experienced Quality Engineer to lead manufacturing quality assessment, remediation, and continuous improvement initiatives for Class II/III medical devices in a regulated manufacturing environment. The ideal candidate will have strong expertise in manufacturing quality engineering, process validation, risk management, CAPA, supplier quality, and regulatory compliance.
Roles & Responsibilities:
- Lead manufacturing quality assessments, process audits, and remediation activities for medical device manufacturing processes.
- Drive First Pass Yield (FPY) improvement, defect reduction, scrap reduction, and manufacturing process improvement initiatives.
- Review and approve process validation (IQ/OQ/PQ) protocols, reports, and supporting documentation.
- Evaluate Test Method Validation (TMV) activities to ensure measurement methods are accurate, reliable, and appropriately validated.
- Conduct and review SPC, MSA, PFMEA, process capability, and statistical analyses to identify and mitigate manufacturing risks.
- Support development and implementation of manufacturing quality improvement strategies and risk-reduction programs.
- Manage and provide technical support for CAPA, nonconformance, deviation, and corrective/preventive action activities.
- Investigate manufacturing defects and quality issues using structured root-cause analysis and problem-solving methodologies.
- Monitor quality metrics, manufacturing trends, process performance, and corrective action effectiveness.
- Support supplier quality activities, including supplier assessments, quality issues, corrective actions, and supplier performance monitoring.
- Review manufacturing processes and quality systems for compliance with applicable regulatory and quality requirements.
- Support FDA, ISO 13485, MDSAP, and other regulatory audits and inspections.
- Collaborate with Manufacturing, Engineering, R&D, Supplier Quality, Regulatory Affairs, and Operations teams to resolve quality issues and implement sustainable improvements.
- Ensure appropriate quality documentation, records, and objective evidence are maintained in accordance with applicable procedures and regulations.
- Identify opportunities for continuous improvement, process optimization, and manufacturing risk reduction.
- Bachelor's degree in Engineering, Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, Quality Engineering, or a related technical discipline.
- Master's degree in Engineering or a related field is preferred
- 8+ years of experience in Medical Device Manufacturing Quality Engineering or a closely related quality function.
- Demonstrated experience with process validation (IQ/OQ/PQ), Test Method Validation (TMV), SPC, MSA, PFMEA, and process capability analysis.
- Hands-on experience managing CAPA, nonconformance, deviation, root-cause analysis, and corrective action processes.
Position Details
Posted:
Oct 28, 2026
Reference Number:
9e36b38d
Employment:
Full-time
City:
Salt Lake City
Job Origin:
ziprecruiter
Share this job:
Verify Email To Complete
Enter the 4 digit code we sent you
via email to continue.
(Check your Spam folder as well)
Didn't get the Code? Resend Code
Please wait..!!