Quality Engineer

Tandem Project Management Limited; Galway; On-site; EUR 55,000 - 75,000; Full time

Job summary

Tandem Project Management Limited in Galway seeks a Quality Engineer to ensure products meet requirements and standards through audits, inspections, and testing. You will drive corrective actions, supplier quality, and a robust QMS while collaborating with teams across engineering, manufacturing, and suppliers.

The role emphasizes defect reduction, process capability, and conformance to regulatory standards in a fast-paced medical devices environment. Galway location, full-time, on-site.

Qualifications

• Third-level Engineering or Science degree.
• 5+ years' experience in a Quality Engineering role.
• Certified Quality Engineer (CQE) preferred.
• Expert knowledge of blueprint reading and GD&T.
• Understanding of QSR/ISO regulations.
• Quality system auditing techniques.
• Design assurance, FMEA, and product testing methods.
• Ability to use optical comparators and CMMs.
• Knowledge of statistics, process control, and process capability.
• Team-based collaborative approach with suppliers and regulators.

Responsibilities

• Analyses quality trends and data and takes corrective action.
• Supports Production with quality-related issues.
• Investigates customer complaints and implements CAPA.
• Qualifies, audits, and monitors suppliers and actions.
• Develops and maintains a quality management system compliant with regulations.
• Formulates procedures, specifications, and standards.
• Provides leadership for quality engineering projects end-to-end.
• Develops and implements corrective and preventive action plans.
• Collects data for gauge and product evaluation.
• Ensures validation activities are documented and compliant.
• Identifies critical personnel, gauges, procedures, and materials for new products.
• Ensures suppliers have required information and facilities for quality.
• Evaluates new suppliers and supports supplier quality requirements.
• Ensures Receiving Inspection is compliant and effective.

Skills

Quality engineering

GD&T

Statistics

FMEA

Audit techniques

Supplier quality

Team collaboration

CMMs / optical comparators

QSR/ISO knowledge

MS Office

Education

Engineering or Science degree

Tools

CMMs

Optical comparators

Microsoft Office Suite

Job description

Summary

A Quality Engineer is required for a leading Medical Devices company based in Galway. The successful candidate will be responsible for ensuring products conform to established requirements and quality standards through effective audit, inspection, and testing activities.

Responsibilities

• Analyses quality trends and data and takes appropriate corrective action.
• Supports Production with all quality-related issues.
• Investigates customer complaints and implements appropriate corrective and preventative actions.
• Qualifies, audits, and monitors suppliers and coordinates supplier corrective actions where necessary.
• Develops and maintains an effective and robust Quality Management System that complies with all relevant regulatory requirements.
• Formulates procedures, specifications, and standards for products and processes.
• Provides leadership for Quality Engineering projects from concept through design, implementation, testing, documentation, support, and maintenance.
• Develops and implements corrective and preventative action plans.
• Collects and analyses data for gauge and product evaluation.
• Ensures all validation activities are effective and documented in a compliant manner.
• Identifies the critical personnel, gauges, procedures, and materials required for the completion of new products.
• Ensures suppliers have the necessary information and facilities to deliver quality products.
• Evaluates new suppliers as required and supports the implementation of supplier quality requirements.
• Ensures the Receiving Inspection process is implemented in a compliant and effective manner.

Qualifications & Experience

• Third-level Engineering or Science degree.
• 5+ years' experience in a Quality Engineering role.
• Certified Quality Engineer (CQE) preferred.
• Microsoft Office Suite.
• Expert knowledge of blueprint reading and geometric dimensioning and tolerancing (GD&T).
• Understanding of QSR/ISO regulations.
• Quality system auditing techniques.
• Design assurance, FMEA, and product testing methods, and ability to use optical comparators and CMMs.
• Knowledge of statistics, process control, and process capability.
• Ability to work within a team environment and build relationships both inside and outside the company (suppliers, regulatory agencies, etc.).
• Facilitates team efforts on quality engineering projects.
• Ability to deliver results and meet deadlines.