Supplier Quality Engineer

Merit Medical Systems•South Jordan, UT

20h

About The Position

At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world. This position evaluates the quality and process controls of Merit suppliers; works with them to develop their processes and quality systems to ensure sustainable compliance to the requirements of Merit, customers and industry standards, and assist them in achieving Merit’s quality goals.

Requirements

Education and/or experience equivalent to a Bachelor's Degree in Engineering or related field.
A minimum of three years of supplier quality and risk management (ISO 14971) experience.
Must have knowledge of Quality Engineering discipline, including statistics.
Must be able to manage project schedules and timelines in a cross-functional environment.
Working knowledge of Lean Manufacturing principles.
Ability to understand, analyze, and resolve complex technical problems.
Excellent interpersonal, and oral and written communication skills.
Problem solving and conflict management skills.
Excellent organizational skills and the ability to work under strict time constraints.
Strong analytical skills and attention to detail.
Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.
Required to travel up to 20% of the time.

Nice To Haves

FDA regulated environment experience.
Medical instrumentation in a regulated environment (i.e. GMPs, ISO13485, EN46001, etc.
Supplier and part management experience.
ASQ Certified Quality Engineer and/or Quality Auditor.

Responsibilities

Maintains the quality performance metrics and requirements for suppliers.
Coordinates the update of Merit documentation to sufficiently describe the products and/or services supplied and the requirements for acceptance.
Maintains the selection, approval and performance evaluation activities needed for suppliers to meet Merit’s specified requirements.
Supports the type and extent of control to be exercised over suppliers based on risk.
Reviews and analyzes data related to supplier approval and performance to specified requirements. Provide reports to management, as appropriate.
Maintains records demonstrating that the specified requirements have been met, including supplier approval, evaluation, audits, corrective and preventative actions.
Facilitates the supplier change notification process to ensure Merit receives advance notification of proposed changes, and approves changes prior to implementation.
Utilizes Supplier Corrective Action Requests to resolve supplier performance problems with Purchasing, Engineering and IQA, as appropriate.
Supports the handling and resolution of supplier related issues using Merit’s risk management process.
Reviews supplier systems and core competencies for gaps that may result in poor quality, including in-process and final inspection processes, and evaluates the need for additional controls at the supplier and Merit to ensure quality levels are maintained or improved.
Coordinates the supplier audit schedule, conducts on-site supplier audits, and evaluates supplier performance.
Reviews Merit’s Receiving Inspection activities/plans for raw components/assemblies/materials purchased from suppliers and associated processes and documentation.
Presents supplier performance metrics and risk updates to management, as required.
Serves as a Merit Quality Liaison for suppliers to ensure effective communication and collaboration between Merit and suppliers.
Performs other related duties and tasks as required.