Senior Supplier Quality & Risk Engineer

300 Merit Medical Ireland, Limited; Galway; On-site; EUR 70,000 - 100,000; Full time

Benefits offered by this job

Attractive Salary package

Defined Contribution Pension Plan

Health Insurance Cover

Life assurance

Health & Wellbeing Events Calendar

Excellent career progression

Job summary

Merit Medical Galway is seeking an experienced professional to establish and maintain supplier quality requirements for externally sourced products and services, and to manage supplier risk. You will ensure supplier process validations, test method validations and specifications meet Merit standards, and you will lead supplier evaluation, audits and change control activities.

Collaborating with Purchasing, Engineering and IQA, you will drive continuous improvement, maintain records, and report

Qualifications

• Bachelor's Degree in Engineering or related field.
• Six years of supplier quality and risk management (ISO 14971) experience.
• 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.

Responsibilities

• Establishes and maintains the requirements, including quality requirements, which must be met by suppliers, contractors or consultants.
• Ensures that Merit documentation sufficiently describes the product and/or services to be supplied and meets the requirements for approval of product; inspection / acceptance procedures, processes and equipment; qualification of personnel and quality management system requirements are understood by suppliers and Merit personnel, as appropriate.
• Establishes the evaluation, selection and re-evaluation processes needed to document the ability of the suppliers, contractors or consultants to meet specified requirements.
• Defines the type and extent of control to be exercised over the product, services, suppliers and consultants based on risk to the finished product and on the supplier evaluation results.
• Reviews and analyses data related to supplier qualification and performance to specified requirements.
• Provide reports to management, as appropriate.
• Maintains records of inspections or other activities demonstrating that the specified requirements have been met.
• Ensures purchasing documents include, where appropriate, an agreement that the supplier shall notify Merit of any changes in the product or services.
• Ensures that changes do not affect the quality of the finished device or its legally marketed regulatory status
• Ensures records of corrective and/or preventive actions arising from the evaluation process and/or supplier approval documentation are maintained and reviewed by management.
• Identify areas of improvement and facilitate process improvement, as appropriate.
• Ensure remediation activities are completed to schedule which include but are not limited to process validation, test method validation, and specification updates throughout the supply base
• Coordinates supplier related problems with Purchasing, Engineering and IQA, as appropriate.
• Ensures that supplier related issues are addressed by Merit’s risk management process.
• Provides input to and manages the department budget.
• Provides adequate qualified resources to meet departmental objectives and support operations and quality needs.
• Performs other related duties and tasks as required.

Skills

Supplier quality

Risk management

ISO 14971

Education

Bachelor's Degree in Engineering or related field

Job description

Merit Medical Galway is seeking an experienced professional to establish and maintain supplier quality requirements for externally sourced products and services, and to manage supplier risk. You will ensure supplier process validations, test method validations and specifications meet Merit standards, and you will lead supplier evaluation, audits and change control activities.

Collaborating with Purchasing, Engineering and IQA, you will drive continuous improvement, maintain records, and report