Senior Supplier Quality 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

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.

Founded in 1987, Merit Medical Systems, Inc. is a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling in excess of 500 individuals. Merit employs approximately 6,000 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Aliso Viejo, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Ontario, Canada; Melbourne, Australia; Tokyo, Japan; Reading, United Kingdom; Johannesburg, South Africa; and Singapore.

UNDERSTAND. INNOVATE. DELIVER. Merit Medical is a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy. Merit has made it a priority to understand customers, innovate, and deliver life-changing products and services.