Summary of Duties
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.
Duties & 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.
Summary of Minimum Qualifications
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
Summary of 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.
Key Benefits
Attractive Salary package
Defined Contribution Pension Plan
Health Insurance Cover
Life assurance
Health & Wellbeing Events Calendar
Excellent career progression opportunities
Recognition scheme
Free Parking
Educational assistance
Internal training courses
Quality Subsidised Canteens & Barista Service
Active Sports and Social Club
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