Quality Engineer

Life Science Recruitment Ltd; Galway; Hybrid; EUR 55,000 - 70,000; Full time

Benefits offered by this job

Salary

share options

pension

hybrid working

healthcare

Job summary

Life Science Recruitment Ltd is recruiting a Quality Engineer for a Galway-based Medical Device company. You will support quality systems, supplier quality and manufacturing with a focus on continuous improvement of products and processes.

You will lead quality activities with outsourced manufacturers, drive risk management and product transfer quality, and ensure regulatory compliance under MDR, FDA QSR and ISO 13485.

Qualifications

• Bachelor's degree or higher in Engineering/Science.
• 2+ years quality or manufacturing in medical devices.
• Knowledge of GMP per US/EU regulations for medical devices.
• Knowledge of ISO 14971 Risk Management applied to QMS.
• Ability to make decisions to sustain supply while maintain compliance.

Responsibilities

• Maintain and improve Quality Management System in line with MDR EU 2017/745, 21 CFR 820 and ISO 13485.
• Lead quality activities with outsourced manufacturers and suppliers for compliance.
• Lead risk management activities including FMEA.
• Drive risk-based problem solving to assure product quality and patient safety.
• Collaborate with cross‑functional engineering to deliver product transfer quality deliverables.
• Oversee process verification/validation per QMS policies.
• Own non-conformances and CAPAs, ensure containment, root cause analysis and corrective actions.

Skills

Quality systems

Risk management

CAPA management

Regulatory compliance

Cross-functional teamwork

Education

Engineering or Science degree

Job description

Title

Quality Engineer

Location

Galway business park, Galway

Benefits

• Salary
• share options
• pension
• hybrid working
• healthcare

Company

My client are a Medical Device company in a growth stage. Dedicated to improving the quality of life for stroke patients. Developing innovative catheter-based technology to extract blood clots from the brain following an Acute Ischemic Stroke, recently received FAD approval.

Culture

• An inclusive work environment, where all the employees are valued, supported, and encouraged.
• All employees have a seat at the table and have influence.
• A collaborative teamwork environment where learning is constant, and performance is rewarded.
• The opportunity to be at the forefront of a technology that can positively impact the treatment of one of the world's most devastating diseases

Overview

As a Quality Engineer you will provide support in quality systems, supplier quality and manufacturing activities with a focus on continuous improvement of products and processes.

Responsibilities

• Support the maintenance of a quality management system that complies with the Medical Device Regulation (MDR) EU 2017/745, the FDA Quality Management System Regulation 21 CFR 820 and ISO 13485.
• Lead quality activities related to outsourced manufacturers and suppliers to ensure compliance is maintained for products.
• Lead risk management activities including hazard/failure mode effects analysis.
• Drive risk-based problem solving to assure product quality and patient safety through both design activities and manufacturing processes.
• Work closely with cross functional engineering colleagues to lead product transfer quality deliverables.
• Lead process verification and validation activities in accordance with quality system policies and practices.
• Own and manage internal and supplier driven non-conformances (NCs) and CAPAs, ensuring timely containment actions, corrections, root cause investigation, implementation of corrective actions, and closure.

Requirements

• Degree in Engineering or Science discipline.
• 2+ years’ quality or manufacturing experience in the medical device industry
• Thorough knowledge of Good Manufacturing Practice as described in US and European regulations for medical device manufacture.
• Excellent knowledge of the application of ISO 14971; Risk Management, throughout the QMS.
• Demonstrated ability to make challenging decisions to support continued supply of products, while also maintaining compliance.