Quality Engineer

Tandem Project Management Ltd.; Galway; On-site; EUR 70,000 - 90,000; Full time

Job summary

Tandem Project Management Ltd. in Galway is seeking a Quality Engineer to ensure products meet requirements through audits, inspections and testing.

The successful candidate will drive continuous improvement, support production, investigate complaints, qualify suppliers, and help implement a robust quality management system in a medical devices environment.

Qualifications

• 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.

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.

Skills

Quality Engineering

CQE preferred

Blueprint reading

GD&T

QSR/ISO regulations

Auditing techniques

FMEA

Product testing methods

Statistics

Process control

Team collaboration

Deadline-driven

Education

Engineering or Science degree

Tools

Microsoft Office Suite

Optical comparators

CMMs

Job description

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.