Senior QA Design Transfer Engineer I
Merit Medical
SUMMARY OF MINIMUM QUALIFICATIONS Education and/or experience equivalent to a Bachelor's Degree in Engineering or related field. A minimum of eight (8) years of engineering experience. Demonstrated working knowledge of 21 CFR 820 (Quality Systems Medical Devices), ISO 13485, ISO14791, and other medical device related standards. Advanced Engligh level TMV, MVP and validations experience (must) Working knowledge of statistical methodologies, quality control and manufacturing tools such as problem solving, root cause investigation, applied statistics, lean manufacturing, Six Sigma, etc., and project management experience. Knowledge of applicable regulatory agency regulations. Demonstrated computer skills, preferably spreadsheets, word processing, database, and other applicable software programs. PREFERRED QUALIFICATIONS Medical device experience or equivalent experience in a regulated industry. Experience with Minitab or JMP, Oracle. Passed ASQ Certified Quality Engineering exam. COMPETENCIES Interpersonal Skills Organization Written and Verbal Communication Teamwork Conflict Resolution Negotiation Problem Solving Decision Making COMMENTS Infectious Control Risk Category II: The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category III states employment and procedures that do not require exposure.
Agosto 14 2026 en Tijuana
