Supplier Quality Engineer

About Merit Medical Systems

Merit Medical is dedicated to designing innovative medical devices to enhance patient lives globally. We foster a collaborative environment that values hard work, teamwork, and commitment to excellence. Our Galway facility began in 1993 and has grown significantly to over 900 employees, boasting a diverse and inclusive workforce with notable achievements like the Medtech Company of the Year Award.

Role Summary

This role involves evaluating and improving the quality and process controls of Merit suppliers. The engineer will work closely with suppliers to develop sustainable quality systems and ensure compliance with Merit’s standards, customer expectations, and regulatory requirements.

Key Responsibilities

• Maintain quality performance metrics and standards for suppliers.
• Update Merit documentation to clearly define product/service specifications and acceptance criteria.
• Manage supplier selection, approval, and performance evaluations to meet Merit’s requirements.
• Apply risk-based controls over suppliers as appropriate.
• Analyze supplier data related to approvals and performance; prepare management reports.
• Keep detailed records of supplier approvals, evaluations, audits, and corrective/preventive actions.
• Oversee supplier change notifications to ensure advance communication and approval of changes.
• Use Supplier Corrective Action Requests to resolve issues in collaboration with Purchasing, Engineering, and IQA teams.
• Support resolution of supplier-related risks through Merit’s risk management framework.
• Assess suppliers’ systems and core competencies to identify quality gaps and recommend additional controls as necessary.
• Coordinate and perform supplier audits onsite; assess supplier performance.
• Review Merit’s raw material/component receiving inspections and related processes/documentation.
• Present supplier performance metrics and risk updates to management.
• Act as the quality liaison between Merit and suppliers to ensure effective communication and collaboration.
• Perform other duties as required.

Required Qualifications and Skills

• Bachelor’s degree in Engineering or related discipline or equivalent experience.
• Minimum five years of experience in supplier quality and risk management (including ISO 14971).
• Thorough knowledge of Quality Engineering principles, including statistical methods.
• Project management skills for coordinating schedules cross-functionally.
• Understanding of Lean Manufacturing principles.
• Strong problem-solving and conflict resolution abilities.
• Excellent interpersonal, verbal, and written communication skills.
• Detail-oriented with strong organizational and analytical capabilities.
• Proficient with computer applications such as spreadsheets, word processing, and databases.
• Available to travel up to 20% of the time.

Preferred Skills and Experience

• Experience working in FDA-regulated environments.
• Background in medical instrumentation quality under GMPs, ISO 13485, EN46001 standards.
• Experience managing suppliers and parts.
• ASQ Certified Quality Engineer and/or Quality Auditor certifications.

Benefits

• Competitive salary package.
• Defined Contribution Pension Plan.
• Health insurance coverage.
• Life assurance.
• Health and wellbeing events.
• Opportunities for career advancement.
• Employee recognition programs.
• Free parking facilities.
• Educational assistance and internal training courses.
• Quality subsidized canteen and barista services.
• Active sports and social club.

Company Culture and Development

Merit Medical Galway emphasizes internal career growth, with nearly 60% of roles filled from within. The company prides itself on a supportive, dynamic, and inclusive workplace that values diversity across gender and nationality. Employees are recognized as individuals and encouraged to develop their potential.