Quality Assurance Engineer II (Molding)
Merit Medical
SUMMARY OF MINIMUM QUALIFICATIONS • Education and/or experience equivalent to a Bachelor's Degree in Engineering or related field with three years quality engineering experience in medical devices. • Prior medical industry experience • Advanced English level • Strong interpersonal, organizational, and verbal and written communication skills and the ability to work effectively as a team member. • Demonstrated working knowledge of 21 CFR 820 (Quality Systems Medical Devices), ISO 13485, ISO14791, and other medical device related standards. • Proven ability to work effectively in a team environment through conflict resolution and negotiations. • Working knowledge of statistical methodologies, quality control and manufacturing tools, such as applied statistics, lean manufacturing, Six Sigma, etc. • 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 handling non-conformances, deviations, investigations and CAPAs. • Experience in revieweing and approving validations for molded products. COMPETENCIES • Engineering techniques/evaluation/selection/application • Engineering variable analysis • Plans/surveys/structures/equipment • Supervisory assistance • Special projects/ECN's/prototype creation • NC causes/corrective actions/dispositions 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 II states employment and procedures that may require exposure.
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