Merit Medical is looking to hire a Quality Engineer to improve the quality of their medical devices and ensure compliance with regulatory standards such as 21 CFR 820 and ISO 13485.
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.
- Medical device experience or equivalent experience in a regulated industry.
- Knowledge of engineering techniques, evaluation, selection, and application.
Responsibilities
- Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications.
- Works independently on standard projects while assistance is furnished on unusual problems.
- 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.
- Reviews, approves and generates 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).
- Evaluates and participates in the selection of suppliers by monitoring supplier performance, through collection and trending of data and performing supplier quality audits, as required.
- Reviews nonconformance records (internal/external) to determine: disposition, root cause and need for corrective and preventive actions.
- Ensures containment (identification, segregation and reconciliation) of nonconforming product has been performed, to prevent unintended use.
Other
- Education and/or experience equivalent to a Bachelor's Degree in Engineering or related field with three years quality engineering experience
- 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.
- Ability to lift up to 50 lbs.
- Ability to work in a environment with noise, chemical vapors, and other physical demands.
