Senior Supplier Quality Engineer

Merit Medical Systems; Galway; Hybrid; EUR 90,000 - 120,000; 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 progressionopportunit

Recognition scheme

Free Parking

Educational assistance

Internal training courses

Quality Subsidised Canteens & Barista

Active Sports and Social Club

Job summary

Merit Medical Galway is seeking a Senior Supplier Quality Engineer to establish and maintain supplier quality requirements and controls across outsourced and supplier-based activities. You will ensure process validations and supplier documentation comply with Merit standards, collaborating closely with Purchasing, Engineering and IQA.

Ideal candidates bring a minimum of six years in supplier quality and risk management (ISO 14971), strong communication skills, and a proven ability to drive

Qualifications

• Education equivalent to a Bachelor's degree in Engineering or related field.
• Six years of supplier quality and risk management experience (ISO 14971).
• Strong communication and coordination skills.
• Ability to work under time constraints with attention to detail.

Responsibilities

• Establish and maintain supplier quality requirements and controls.
• Ensure supplier QA documentation and approval processes meet Merit standards.
• Coordinate with Purchasing, Engineering and IQA on supplier-related issues.
• Maintain records of inspections and corrective actions.
• Lead process improvement initiatives across the supply base.

Skills

Interpersonal skills

Oral and written communication

Problem solving

Organizational skills

Analytical skills

Education

Bachelors in Engineering or related field

Tools

Spreadsheets

Word processing

Database

Job description

## Senior Supplier Quality EngineerApply: Galway, Ireland: Full time: Posted Today: JR117479**Why Merit?**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.**SUMMARY OF DUTIES**This position is responsible to establish and maintain procedures ensuring that all purchased and received product and services (outsourced, subcontractors and consultants) conform to specified requirements. This position is responsible to ensure that supplier process validations, test method validations and specifications are conforming to requirements.**DUTIES & RESPONSIBILTIES** * 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.**SUMMARY OF MINIMUM QUALIFICATIONS** * Education and/or experience equivalent to a Bachelor's Degree in Engineering or related field.* A minimum of 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.#IJA***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***We are Global***Merit Medical Galway commenced with 22 employees in 1993. Since then Merit has enjoyed year on year revenue growth and developed its workforce to over 900 employees. Headquartered in Salt Lake City, Utah, Merit maintains a diverse, multi-campus manufacturing footprint in Europe, North America, South America, Asia and Australia with a global distribution.***Medtech Company of the Year Winner***Merit Medical Galway are proud winners of the Medtech Company of the Year Award, a prestigious award recognizing those who are exceling in the MedTech industry.***People Development***At Merit Medical Galway almost 60% of all roles are filled by internal employees! We focus on encouraging, believing in and providing a platform for you to progress your career!***Culture***A supportive and collaborative environment make Merit Medical a friendly, enjoyable place to work. We are proud of our energetic and dynamic culture. Diversity & Inclusion is evident here with an 50/50 ratio of male and female employees as well as 30 nationalities onsite! We value every employee as an individual.To see more on our culture, go to www.merit.com/careers.