Quality Engineer TPM6090

Tandem Project Management Ltd.; Galway; Hybrid; EUR 60,000 - 80,000; Full time

Job summary

Tandem Project Management Ltd. in Galway is seeking a Quality Engineer to ensure products conform to established requirements and quality standards through audits, inspection, and testing.

The role focuses on leading quality initiatives, supplier quality, data analysis, and robust QSR/ISO compliance to support medical device development and manufacturing in a collaborative team 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 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 with suppliers and regulatory agencies.
• 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 corrective and preventive actions.
• Qualifies, audits, and monitors suppliers and coordinates supplier corrective actions where necessary.
• Develops and maintains an effective Quality Management System that complies with 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.
• Identifies critical personnel, gauges, procedures, and materials for new products.
• Ensures suppliers have necessary information and facilities to deliver quality products.
• Evaluates new suppliers and supports supplier quality requirements.
• Ensures the Receiving Inspection process is implemented effectively.

Skills

GD&T

Statistics

Process control

Process capability

FMEA

Quality audits

Education

Bachelors degree in Engineering or Science

CQE certification preferred

Tools

Microsoft Office

Optical comparators

CMMs

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.