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 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.
#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 .
