Merit Medical is looking to hire a Quality Engineer to perform routine quality engineering work for specific product lines, focusing on improving quality systems and documentation to ensure the quality and effectiveness of medical devices.
Requirements
- Demonstrated working knowledge of 21 CFR 820 (Quality Systems Medical Devices), ISO 13485, ISO14791, and other medical device related standards.
- 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.
- Experience with SmartCAPA, Oracle and Crystal Reports.
- Experience handling deviations, investigations and CAPAs.
- Standard engineering techniques/procedures/criteria
- NC causes/corrective actions/dispositions
Responsibilities
- Performs routine quality engineering work for specific product lines under general supervision and guidelines.
- Responsibilities include: failure investigation, oversight/determination of disposition of nonconforming materials, conducting and updating risk analysis documentation and processes, defining/refining quality inspection plans, performing data collection and trending for presentation of key metrics, identifying and addressing supplier quality issues, reviewing and generating validation/protocol data, and optimizing and improving quality systems and documentation.
- Responsible for risk management documentation for assigned product line(s) or processes; and identifying and updating failure modes and related process/product improvements by facilitating teams and implementing required changes.
- Reviewing, approving and generating Engineering Change Notifications (ECNs) to update or generate: verification, validation, monitoring and inspection methods, procedures, and test protocols; specific to assigned product line(s) and processes and production control(s).
- Evaluating and participating in the selection of suppliers by monitoring supplier performance, through collection and trending of data and performing supplier quality audits, as required.
- Reviewing nonconformance records (internal/external) to determine: disposition, root cause and need for corrective and preventive actions.
- Identifying and implementing any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system through the use of: quality policy, quality objectives, audit results, analysis of data, etc.
Other
- Education and/or experience equivalent to a Bachelors Degree in Quality Engineering or related field, or a Masters Degree.
- Strong interpersonal, organizational, and verbal and written communication skills and the ability to work effectively as a team member.
- Proven ability to work effectively in a team environment through conflict resolution and negotiations.
- Lifting -- Not to exceed 50 lbs.
- Risk category II: employment and procedures that may require exposure.
