Supplier Quality Engineer

Supplier Quality Engineer

Requirements

• Education and/or experience equivalent to a Bachelor’s Degree in Engineering or related field.
• A minimum of five 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.

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.

Preferred Qualifications

• 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.