Quality Assurance Manager

Life Science Recruitment; Galway; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Top salary

Bonus

pension

healthcare

Job summary

My client in Galway is seeking a Quality Manager to lead the QMS for a medical device hub. You will ensure compliance with ISO 13485, ISO 9001, and 21 CFR Part 820, while driving CAPA, auditing, and continuous improvement. Strong leadership and technical writing are essential.

Qualifications

• Extensive experience in quality assurance and control in medical device manufacturing or related industry.
• In-depth knowledge of manufacturing processes and quality systems.
• Strong leadership and regulatory compliance capabilities.

Responsibilities

• Ensure QMS processes and documentation meet ISO 13485, ISO 9001, and 21 CFR Part 820.
• Lead internal quality audits and manage CAPA, complaints, and feedback.
• Oversee documents, records, and management reviews per regulatory requirements.
• Provide direction on QA matters including quality systems, compliance and product disposition.
• Manage supervisory responsibilities including hiring, training, performance, and development.

Skills

Leadership

Regulatory awareness

Auditing

CAPA management

Documentation

Education

Bachelor's degree in Engineering or Quality Management

Tools

FMEA

DOE

SPC

Job description

Job title: Quality Manager Location: Galway Company: My client are a Medical device manufacturer with a new hub in Galway. They specialise in catheters, medical balloons, EM-Micro Sensors, engineered shafts, and complete device assemblies, supporting a wide range of interventional therapies. Responsibilities: Ensure the QMS processes and documentation are established, implemented, and maintained in compliance with ISO 13485, ISO 9001, and 21 CFR Part 820. Promote awareness of regulatory and customer requirements across the organization and ensure compliance. Serve as the primary liaison with customers and certification bodies for external audits. Provide leadership and direction on all QA-related matters, including quality systems, compliance, and material disposition. Ensure management review meetings are conducted in accordance with regulatory requirements. Oversee control of documents and records related to products, manufacturing processes, and the QMS. Plan, manage, and conduct internal quality audits to ensure compliance with applicable standards and internal procedures. Handle and monitor CAPA, customer complaints, and feedback to ensure timely resolution and continuous improvement. Carry out supervisory responsibilities in accordance with company policies and applicable laws, including interviewing, hiring, training, performance management, and employee development. Plan, assign, and direct work; evaluate performance; recognize achievements; address employee concerns. Requirements: Education/Experience and Qualifications: 510 years of progressive experience in quality assurance and control within medical device manufacturing or a related industry, with in-depth knowledge of manufacturing processes and quality systems. Strong management and leadership skills. Solid knowledge of ISO 13485, FDA 21 CFR Part 820, and/or Medical Device Directives. Demonstrated proficiency in engineering and quality tools (e.g., FMEA, DOE, SPC, and statistical analysis tools). Ability to support product development, manufacturing, and product release activities as directed by senior management. Excellent technical writing and verbal communication skills.

• Benefits: Top salary, Bonus, pension, healthcare