Senior Manufacturing Quality Assurance Engineer
On-site · South Jordan, Utah, United States
Job Summary
The Senior Manufacturing Quality Assurance Engineer at Merit Medical provides extensive quality engineering support, mentoring, and training of quality assurance staff. Responsibilities include conducting studies to solve technical problems, managing risk analysis, approving Engineering Change Notifications (ECNs), evaluating suppliers and quality audits, and ensuring compliance with quality systems and regulatory standards. Required qualifications include a Bachelor's degree in Engineering, six years of quality engineering experience, and strong knowledge of medical device regulations. Preferred qualifications enhance candidates' marketability through additional experience in regulated industries and statistical analysis.
Required Qualifications
- Bachelor's Degree in Engineering or related field
- Six years of quality engineering experience
- Strong interpersonal, organizational, verbal and written communication skills
- Demonstrated working knowledge of 21 CFR 820, ISO 13485, ISO 14791
- Proven ability to work effectively in a team environment
- Working knowledge of statistical methodologies, quality control, and manufacturing tools
- Knowledge of applicable regulatory agency regulations
- Demonstrated computer skills preferably spreadsheets, word processing, database and other software programs
Desired Qualifications
- Medical device experience or equivalent experience in a regulated industry
- Experience handling deviations, investigations and CAPAs
- Experience with MasterControl, SmartCAPA, Oracle and Crystal
- Statistical Analysis (Green Belt / Black Belt)
Additional Requirements
- Military Veterans are encouraged to apply
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